case study on designer babies

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“ Designer babies ?!” A CRISPR ‐based learning module for undergraduates built around the CCR5 gene

Jay n. pieczynski.

1 Department of Biology, Rollins College, Winter Park Florida, USA

Hooi Lynn Kee

2 Department of Biology, Stetson University, DeLand Florida, USA

Associated Data

Figure S1 . Alignment of various CCR5 alleles against unmodified CCR5 allele. Top window shows the unmodified CCR5 allele, and the bottom window shows the alignment with (a) Δ 32 allele, (b) Nana +1 allele, (c) Nana Δ4 allele and (d) Lulu Δ15 allele. Red boxes highlight mismatches, and red asterisk indicates stop codon that resulted from frameshift.

Figure S2 . Student pre‐ and post‐survey self‐reports on the (a) effectiveness of CRISPR‐cas9 technology in learning how authentic biology research is conducted and (b) ability to apply tools learnt to experimental research and design.

Table S1 . Bioethical Discussion Question on CRISPR germline editing

Table S2 . CCR5 CRISPR‐cas gene editing‐specific Discussion Questions

Table S3 . Rubric for Assessing Student Learning Objectives in Research Proposal

Table S4 . Rubric for Assessing Student Learning Objectives for Podcast Assignment

Table S5 . Useful links

CRISPR‐cas technology is being incorporated into undergraduate biology curriculum through lab experiences to immerse students in modern technology that is rapidly changing the landscape of science, medicine and agriculture. We developed and implemented an educational module that introduces students to CRISPR‐cas technology in a Genetic course and an Advanced Genetics course. Our primary teaching objective was to immerse students in the design, strategy, conceptual modeling, and application of CRISPR‐cas technology using the current research claim of the modification of the CCR5 gene in twin girls. This also allowed us to engage students in an open conversation about the bioethical implications of heritable germline and non‐heritable somatic genomic editing. We assessed student‐learning outcomes and conclude that this learning module is an effective strategy for teaching undergraduates the fundamentals and application of CRISPR‐cas gene editing technology and can be adapted to other genes and diseases that are currently being treated with CRISPR‐cas technology.

1. INTRODUCTION

CRISPR‐cas technology is touted as the “game‐changing technology” for its ability to modify nature at its most fundamental level through the programmable editing of DNA with precision and speed. CRISPR‐cas technology is bound to impact medicine, agriculture, biosphere, and potentially future generations of humans. Broadly speaking, we wondered what the extent of mid to upper‐career science student knowledge was on CRISPR‐cas‐based technology and its uses. Thus, to determine the prior knowledge level of CRISPR‐cas based technologies, we surveyed undergraduate sophomore‐ junior‐ level Genetics students at the onset of the semester. Pre‐surveys indicated that 76.5% of students (13/17) in a Genetics course were minimally aware of CRISPR‐cas technology, while the remainder of the students either had not heard of the technology or were not sure if they had heard of it. Of the students identifying as aware of this technology, our survey results indicated their knowledge concerning CRISPR mostly came from a previous course; however, the news, social media, podcasts/radio and textbooks were also cited as sources for this information. The results of this questionnaire indicated that CRISPR‐cas associated technologies are becoming fundamental components of an undergraduate STEM curriculum, even at the introductory level. Interestingly, although many students had been previously introduced to CRISPR technology, when asked to elaborate on the depth and extent of their knowledge, 66.6% of written responses were coded as “I don't know” or “I can't remember.” Of students remaining, 33.4% of students with a cursory knowledge of CRISPR, comments focused on the novelty and basic components of this technology, however their descriptions lacked accuracy or in‐depth discussion of its applications. Thus, although student knew of its existence or were formally introduced through course work in other courses, this informal survey demonstrated that most students did not have or retain a comprehensive understanding of CRISPR‐cas technology and its diverse uses.

CRISPR‐cas systems, originally identified as an adaptive immune response in bacteria against phages by yoghurt company Danisco, 1 , 2 have been repurposed by scientists for genome‐engineering applications in basic science (reviewed in Chen and Doudna. 3 Recently, the technology provoked a significant reaction that swept through the scientific community. In November of 2018, Dr. He Jiankui claimed to have produced the first human babies born with CRISPR‐cas edited genomes, 4 affirming predictions that germ‐lined edited “designer babies” were coming soon. 5 Specifically, germline CRISPR genomic editing technology was purportedly used to create two baby girls, where the gene encoding C‐C chemokine receptor type 5 (CCR5) was manipulated in in vitro fertilized human embryos. CCR5 functions as a G protein‐coupled receptor (GPCR) to chemokines in immune cells, but also acts as a coreceptor for human immunodeficiency virus (HIV). 6 These “CRISPRed” embryos were implanted, resulting in pregnancy and birth of twin girls with modified CCR5 genes, and thus have become the first known births of genetically modified humans using CRISPR technology 7 , 8 (Table 2). Although Dr. He's work was largely carried out in secret, online documentation showing his study objectives published in the Chinese Clinical Trial Registry 9 indicates that these types of scientific studies are currently being implemented. The success of these experiments has hastened the debate over the bioethical implications and the guidelines in human heritable germline editing, but also highlighted the immediate need for both current instruction on genome editing technologies and bioethical discussions in the classroom.

Advancements in the ability to edit genomes of organisms have permanently changed the landscape of science education particularly in areas of molecular genetics. In the 1980s, the identification and uses of restriction enzymes and Polymerase Chain Reaction (PCR) ushered in the revolutionary recombinant DNA technology, leading to instructional design and curricula changes in biology education. Thirty plus years later, genomic editing via CRISPR‐cas‐based systems has necessitated further change to curricula. One such example is textbook resources. Many recent editions published just a few years ago lack deep descriptions and applications of CRISPR technologies. Although this is surely to change, the speed of the science will always outpace the rate of textbook publication. From a content perspective, working with recombinant DNA requires students to understand and apply specific fundamental molecular concepts; for example, that DNA is double stranded and antiparallel, the structure and components of plasmids, specificity of restriction enzymes, and the theory of PCR amplification using primers and heat‐stable DNA polymerases. With CRISPR‐cas‐based approaches, students are required not only understand the basic concepts above, but also adequately understand and apply additional molecular concepts such as hybridization between DNA and functional RNA molecules, cas‐nuclease activity, endogenous DNA repair mechanisms, the effect on reading frames/codons, loss‐of‐function and gain‐of‐function effects, and genotype–phenotype relationships.

A bevy of evidence suggests a common set of student misconceptions concerning molecular genetics. 10 , 11 , 12 , 13 , 14 Traditionally, instruction has relied upon these core molecular concepts being reinforced in a laboratory setting, where these misconceptions may be addressed through hands‐on application‐based lab work. CRISPR‐cas‐based methodologies have been used successfully to train students in fundamental molecular biology skills 15 and in a variety of model organisms, including yeast, 16 , 17 , 18 Escherichia coli , 19 Drosophila melanogaster , 20 and Arabidopsis thaliana . 21 However, not all undergraduate teaching laboratories are equipped to sufficiently perform gene editing experiments in live organisms and conduct the subsequent molecular and phenotypic analysis, let alone provide high impact course‐based undergraduate research experiences (CUREs) for students using the technologies. Additionally, not every institution requires genetics or molecular biology courses to have an experiential learning opportunity in the lab. Despite these barriers, evidence suggests that students can achieve meaningful learning gains by performing alternative activities such as interactive computer simulations, 22 , 23 , 24

kinesthetic modeling activities, 25 , 26 or case‐based learning modules. 27

CRISPR‐cas‐based genomic editing tools are becoming commonplace in both research and in higher education, necessitating critical dialogues on ways to effectively bring this technology into the undergraduate classroom. We asked whether we can provide effective instruction on genomic editing technologies in educational settings where wet‐lab resources are unavailable, are cost prohibitive, or in situations that require on‐line learning. Can students still understand and apply the principles of CRISPR without physically performing gene‐editing experiments on organisms or cells in lab? Researchers in lab spend a considerable amount of time devoted to the technical aspects of CRISPR‐cas‐based studies, including designing the tools to generate the type of modification desired, target cells/tissues, germline vs. somatic modification, and mode of delivery of CRISPR‐cas tools. Thus, we sought to build a case‐based learning module that centers around the technical design, implementation, and consequence of CRISPR‐cas gene editing.

Using the manipulation of the gene CCR5 in human embryos as a model example, we describe the design and organization of a gene editing experiential lesson where students apply key concepts in molecular genetics to learn the principles of a specific CRISPR‐cas editing design strategy and analysis of the molecular and phenotypic outcomes, with an intentional focus on the bioethics associated with this technology (Figure ​ (Figure1). 1 ). We specifically are focusing on the use of the cas9 endonuclease due to its popularity, ease, and ubiquitous use in many CRISPR‐based manipulations. We combined computer‐based work utilizing basic bioinformatics and sequencing software with modeling to educate students on the essential background, planning and design of CRISPR‐cas9‐based edits. We then challenged students to demonstrate their transference of knowledge from the CCR5 case‐based module by having them investigate and propose their own research projects utilizing CRISPR‐cas‐technologies. Our learning outcomes and student work are described in Table ​ Table1. 1 . When assessed, we determined that our CCR5 case‐based learning module was an effective method for introducing the fundamental technical aspects of molecular genetics and importantly CRIPSR‐cas system. We found that students are eager to learn about CRISPR‐cas technology and its applications in today's world, and students gain a deeper understanding of the mechanisms behind the technology that has significant power to change human biology.

Overview of the CRISPR‐cas case‐based learning module workflow. The center green box shows the flow of the central dogma of molecular biology. The purple boxes on the left show how comparison of unmodified CCR5 allele and modified alleles are compared to enable analysis of the genotypic and phenotypic effects of CRISPR‐cas modifications. The blue boxes on the right show three sequential student activities centered on the technical and application of CRISPR‐cas editing strategy

Learning outcomes and activities for case‐based learning module

2. MATERIAL & METHODS

2.1. intended audience and learning time.

This work is intended for sophomore‐ and junior‐level undergraduate Biology students enrolled in a Genetics or Biotechnology course, but can be integrated and modified for Introductory Biology course or upper‐level Molecular Biology course. The main activity was implemented during a 2‐hour 45‐minute laboratory period. The activity can be adapted to fit two traditional 90‐minute class/lecture periods. Subsequent post‐activity student work where students created a research proposal was carried out over the next two laboratory periods and during students' own time.

2.1.1. Prerequisite student knowledge

Student should have prior exposure to basic molecular genetics principles that include DNA/RNA structure, codons, reading frames, mutation. However, this lesson can be adapted to introduce and apply the concepts of codons/mutations.

2.2. Materials

Each student will require a computer/laptop with access to the internet and the software program, SnapGene Viewer (full version, https://www.snapgene.com ). A free 30‐day trial to SnapGene Viewer can be downloaded by each student with their email address. Alternative molecular biology software could be used with modifications to the below resources.

The student handouts and accompanying instructor guide/key are provided in Supporting Information .

2.3. Instructions for faculty and students

2.3.1. comparative analysis of ccr5 gene and modified allele variants on paper.

The activity utilizes the gene encoding human CCR5; the intended target gene used in Dr. He's study. CCR5 gene encodes for a chemokine GPCR in T cells, and was targeted because of the known role of the CCR5 as a co‐receptor in HIV infection of humans. 28 CCR5 delta 32 (Δ32) is a naturally occurring allele lacking 32 nucleotides that correspond to a sequence that normally codes for part of the co‐receptors second extracellular loop. 28 Removing these 32 nucleotides results in a premature stop codon due to frameshift, and the resultant truncated protein product can no longer be exocytosed to the cell membrane. 29 Individuals homozygous for the CCR5 Δ32 variant are resistant to HIV infection, as CCR5 is required for membrane fusion during HIV infection. The HIV life cycle and the key molecular components of a HIV infection cycle in immune T cell can be introduced to students using this animation by Janet Iwasa. 30

Dr. He's goal of editing human embryos was to create a similar non‐functional HIV‐resistant CCR5 variants using CRISPR‐cas technology. 31 However, the results of these experiments have purportedly generated three new CCR5 allelic variants named after the twin girls, Lulu and Nana, with Lulu being heterozygotic for a novel CCR5 variant (the Lulu CCR5 allele) and wild‐type allele, and Nana being heterozygotic at the CCR5 locus (Nana CCR5 alleles 1 and 2 respectively). 4 , 31 He also claimed that a third child has been genetically modified in a similar manner.

To begin their comparative analysis of the different alleles, students were given a worksheet ( Supporting Information ) that contains the partial coding DNA sequences of an unmodified CCR5 allele, the HIV resistant allele Δ32 CCR5 , and three novel alleles generated via CRISPR‐cas9‐based modification. They were tasked to determine the nucleotide differences between them and the effect on the reading frame, codon and amino acid (Figure ​ (Figure2a, 2a , example of student work; Table ​ Table2, 2 , summary of CRISPR alleles). Students worked on their own initially and then in a group to compare answers.

Student work aligning unmodified CCR5 allele to HIV resistant Δ32 and CRISPR‐cas modified alleles (a) on paper, and (b) using computer software program SnapGene. B) shows all alleles aligned to the unmodified allele. Panel (c) shows an expanded alignment view with the change in reading frame and early stop codon (red asterisks). Expanded alignment views for other modified alleles are shown in Figure S1

The effect of CCR5 mutant alleles on reading frame and protein structure

2.3.2. Comparative analysis of CCR5 gene and modified allele variants on computer

Students were guided to obtain the full reference coding sequence of CCR5 from NCBI (Accession number NM_000579). They created a “new sequence” in the DNA analysis software SnapGene. Students were tasked to create “new features” that represent the three exons to show where intron/exon boundaries would exist in genomic DNA. Using the open reading frame feature, the students determine the translated protein sequence and normal length of protein. They were given the three other new allele variants (Δ32, Lulu, Nana allele 1 and Nana allele 2) that had been created by the instructor based on reported CRISPR modified sequences. 32 Students were guided to align these sequences together and determine the nucleotide, reading frame, amino acid sequence and protein length changes that were created. The use of the full version SnapGene is key in visualizing the alignment. Although NCBI and free DNA softwares ApE and Benchling enables alignment of sequences together, the alignment in Snapgene is presented in an effective scheme that enables students to still visualize the double‐stranded DNA molecule with polarity of each DNA strain, the resulting translation, and the features labeled in one window (Figure 2b,c , Figure S1 ). Students compared their analysis on SnapGene to their worksheet. Using SnapGene allows students to determine whether premature stop codons are formed further downstream from the nucleotide change.

2.3.3. Predicting the effect of the mutations on protein structure

The nucleotide sequence alignment allows students to visualize the effect on the linear primary sequence of the protein, but it is important that students move beyond the linear protein sequence and establish the effects of changes in the primary sequence to the tertiary structure. Students were shown published tertiary structures of the CCR5 protein 33 , 34 where the unmodified protein consists of seven transmembrane helices, characteristic of all G protein‐coupled receptors. Additionally, the web‐based 3D structure viewer iCn3D can be used by students to visualize the tertiary structure of the protein. The students were tasked to discuss and predict how the new alleles affect protein structure and draw the various predicted protein structures out on paper. Students of the Advanced Genetics class utilized the software BioRender ( https://biorender.com ), a free biology drawing software to create their schematics. Examples of student work are shown in Figure 3a,b .

Student work depicting protein structure of CCR5 and predicted structures of its various modified versions (a) on paper and (b) using Biorender. Nucleotide sequences that were inserted or deleted are indicated, and nucleotides shared between Δ32 and Nana+1 alleles are highlighted

2.3.4. CRISPR ‐cas9 editing design and strategy of CCR5 gene

Students were guided to design the strategy to program the cas9 nuclease to target and cut CCR5 gene at the appropriate region in order to create a loss‐of‐function CCR5 protein. Specifically, students identified and designed 3 key components: (a) the cas9 nuclear target sequence in CCR5 , (b) the protospacer adjacent motif (PAM) sequence in CCR5 gene utilized by cas9, and (c) the complementary guide RNA that is guided to the target sequence by cas9 (Figure ​ (Figure4 4 ).

Necessary components for CRISPR‐cas9‐based genetic modifications. (a) cas9 and gRNA form a complex, then gRNA base pairs with complementary sequence in CCR5 gene with PAM aiding in bringing cas9 nuclease in, resulting in cas9 double‐stranded cleavage 3 nucleotides from PAM sequence. (b) A comparison of endogenous DNA repair mechanisms, non‐homologous end joining (NHEJ) and homology directed repair (HDR), which utilizes a repair template containing the desired nucleotide change. Nana alleles Δ4 and +1 are shown as outcomes of NHEJ, and HIV resistant Δ32 is shown as an outcome of HDR with the use of an appropriate repair template

Using the reference unmodified CCR5 gene, students utilized the “features” tool on SnapGene to identify and annotate the cas9 specific PAM sequence (5′NGG3′) chosen by Dr. He that was presented in his oral presentation at the Second International Summit on Human Genome Editing meeting (Start at: 1:17:57). 8 The guanine dinucleotides of the PAM sequence that is on the non‐target strand of the gRNA interacts with arginine amino acids of cas9 to assist the unwinding of double‐stranded DNA for subsequence nuclease activity (as reviewed in Chen and Doudna 3 ). Next, students were guided to label the target sequence of the cas9 nuclease, which are the 20 nucleotides upstream of the 5′TGG3′ PAM sequence (Figure ​ (Figure5a). 5a ). The cas9 nuclease is brought to the target sequence by the single guide RNA, which is composed of an RNA sequence complementary to the target strand and an 80‐mer universal scaffold region that aids in cas9 binding. To model formation of gRNA‐cas9‐target DNA complexes, students were tasked to hand draw how all these components interact, labeling important components and sites including their PAM sequence, the location of the cas9 cut site, the annealing of the gRNA to its specific target nucleotide sequence. We intentionally had students draw this out based on our prior teaching experiences where assessment revealed students found it challenging to conceptualize the action and polarity of gRNA and cas9 complex with two complementary DNA strands (target and non‐target strands) of the target gene. 19

Key components utilized by CRISPR‐cas9 system. View in SnapGene of (b) PAM sequence (green) and gRNA‐cas9 target sequence (light green) are annotated in unmodified CCR5 allele in top half. Potential PAM sequences are highlighted in yellow. Bottom half shows the alignment with Δ32 allelic variant to allow visualization of which PAM sequence is most appropriate. (b) An example HDR repair template lacking the 32 nucleotides missing in the Δ32 allelic version, and containing two homology arms. The blue line indicates where the 32 nucleotides in Δ32 allelic version has been deleted. (c) Student work showing a schematic of gRNA and cas9 complexing with target sequence in optix gene

Students were prompted to discuss why this specific PAM associated with the target sequence was chosen of all possible PAM sequences of (5′NGG3′) as a quick “Find” of “GG” highlights in yellow all the GGs present in the sequence (yellow boxes, Figure ​ Figure5a), 5a ), and students observe that there are many potential PAM sequences present throughout the gene. The discussion led the class to conclude that this specific 5′NGG3′ was chosen of many potential 5′NGG3′ because of the necessity for cas9 cut the CCR5 genomic DNA in close proximity to the physical location of the desired nucleotide change that could potentially give rise to Δ32 allele variant.

2.3.5. Interpreting DNA repair mechanisms that created Nana and Lulu alleles; designing a homology directed repair ( HDR ) repair template

Identification of the likely CCR5 PAM sequence and cas9 cut site was followed by discussion of the outcomes for the CCR5 gene after cas9 cleavage, and how different endogenous repair mechanisms are used to achieve different research goals. Animation are shown to illustrate the two processes. 35 , 36 The process of non‐homologous end joining (NHEJ) is used after cas9 makes the double stranded cut to produce indels and potential loss‐of‐function alleles due to frameshift mutations. Homology Directed Repair (HDR) is typically utilized when a specific nucleotide change is desired. HDR requires the addition of a repair template with homology arms that enables the cell to utilize HDR to incorporate a desired nucleotide sequence after the cas9‐mediated dsDNA cut. As a class, we discussed the features that the HDR must contain: (a) the desired nucleotide change, (b) regions of DNA that were similar to the original allele (homology arms), and (c) a PAM sequence that was altered such that the repair template would not be cut by cas9. Students were guided to create an HDR template in SnapGene (Figure ​ (Figure5b). 5b ). Students were then asked to work in groups to discuss which DNA repair strategy was likely utilized by Dr. He to produce the three new variant alleles found in Nana and Lulu. Most students report that NHEJ occurred in the embryos to create the three new variants and that a repair template was likely not used as the HIV resistant Δ32 allele was not found in Lulu and Nana.

2.3.6. Putting knowledge into practice: CRISPR ‐cas9 gene editing strategy with butterfly wing patterning gene optix and human oncogenic Ras gene

Students worked on two follow‐up hypothetical scenarios to practice the CRISPR design and strategy of sgRNA and target sequence. The first scenario was that students were investigating the function of the gene optix in Lepidoptera butterflies, and were tasked to design a CRISPR‐cas9 strategy to create a loss‐of‐function optix gene. The students were shown published results of a CRISPR‐cas9 strategy, where optix CRISPR‐ed butterflies displayed color and patterning defects. 37 An example of student work is shown in Figure ​ Figure5c. 5c . The second scenario was that they had cultured cancer cells growing in lab with Ras gene that has the oncogenic mutation that causes abnormal cell proliferation. 38 , 39 The students' goal was to design a strategy to take this mutant Ras and genetically modify it to wild‐type Ras. They were given the coding sequence for the Ras gene in SnapGene with the oncogenic mutation causing 12th amino acid Glycine to Valine change (G12V). Students were asked to discuss in pairs what they would predict the phenotypic change would be after successful gene edit. The work was submitted to be checked by the instructor.

2.3.7. Bioethics discussion on implications of CRISPR ‐cas9 technology and CCR5 editing in human society

Following the exercise, we engaged the students in a robust bioethical discussion on the bioethical implications of CRISPR‐cas9 technology and the modification of the CCR5 gene. Questions that were posed to students for discussion are included in the Tables S2 and S3 . One topic was the discussion of the novel and Δ32 mutations on CCR5's normal function in human health and disease. Whether Dr. He's novel CCR5 mutations in the twins actually confer HIV protection or has an effect on normal immune function has not been published yet. We asked students whether Lulu and Nana should be monitored by a specialized group of doctors and researchers for unintended consequences of their genetic edits since they have novel modified alleles that have not been studied before. Since Dr. He's made his claim, studies show that humans who are carriers for the Δ32 CCR5 allele have a faster recovery from strokes. 40 Furthermore, CCR5 plays a role in brain cognition, as mice that lack CCR5 have improved memory. 41

3. RESULTS AND DISCUSSION

3.1. student learning of crispr ‐based concepts.

To assess if students could effectively learn the basics of CRISPR‐based gene editing, without traditional “wet laboratory” bench‐based manipulations, we deployed a “dry lab” computer‐based module using human germline editing of CCR5 as a case‐based learning study. This was implemented in two separate courses at a primarily undergraduate institution (PUI) in Spring 2018 semester. Courses were designed for mid to upper level science majors (300‐level Genetics course with 17 students, and 400‐level Advanced Genetics course with 11 students) with a vested interest in advanced topics in genetics and genetic engineering. In general, students were enthusiastic about studying CRISPR‐cas technology, especially using an example that was a very recent and controversial development in the field. Our learning objectives (Table ​ (Table1) 1 ) were framed around core components of CRISPR‐cas editing, focusing on the technical design and outcomes of gene editing concepts. To assess student achievement of these learning objectives, we chose not to formally assess student work on the CCR5 gene, as this work was instructor guided. Instead, we assessed students on learning objectives in a post‐activity assignment where students could effectively showcase their knowledge (Table ​ (Table3, 3 , Table S3 /Rubric).

Student learning objectives for application of CRISPR‐cas in research proposal

Pre and post‐surveys asked students to “explain their current understanding of how the process of CRISPR‐cas gene editing works, and describe the molecular components, and how they utilized by the system.” In pre‐surveys, most answers were unacceptable (93.33%) or developing (0.07%), and in post‐surveys there is an increase in students' understanding of CRISPR‐cas9 technology with 50% achieving acceptable or higher (Figure ​ (Figure6). 6 ). These results indicate that the use of a case‐based module is an effective strategy for disseminating the fundamentals of CRISPR‐cas‐based technology.

Student pre‐ and post‐survey responses to the question “Explain your current understanding is of how the process of CRISPR‐cas9 gene editing works. What are the molecular components, and how are they utilized by the system?”

Our ultimate goal of this exercise is for students to then be able to apply their acquired knowledge, requiring them to demonstrate knowledge beyond simple comprehension and reiteration of facts. We therefore asked students to complete exercises demonstrating their ability to apply CRISPR‐related concepts to novel scenarios. Students in our 300‐level Genetics cohort were tasked to create a research proposal that asks a scientific question utilizing CRISPR‐technology in their organism of choice (Table ​ (Table3). 3 ). Specifically, students determined a gene of their choice that they would like to modify and proposed how they would phenotypically assay the success of their edit. Some students were initially overwhelmed by the open‐ended nature of the research proposal, but once they started investigated their gene of interest, they became more engaged. Student and faculty hesitation with novel research in courses are not uncommon; however, there is overwhelming evidence to suggest that once adopted, novel research is an effective teaching and learning practice. 42 , 43 , 44 , 45 , 46

Students proposal topics and results of assessment are summarized in Table ​ Table4. 4 . Students were assessed on their justification of their gene and desired change, and 77.78% of students achieved acceptable or higher in their justification. Assessment showed that all students could describe their CRISPR‐cas strategy in their proposal through accurately determining appropriate target sequence and PAM sequence in desired gene, and designing the gRNA and repair template utilized to make their desired nucleotide change. This shows transference of knowledge from the CCR5 exercise, and that students were able to master the technical aspects of CRISPR‐cas9 technology design. However, 66.67% of students achieved the learning objective of effectively describing how the effect of the gene modification would be measured and their expected results and challenges. Achieving this learning objectives requires higher order thinking in terms of the relationship between genotypes and phenotypes by determining and describing a valid assay to measure the success of their gene modification. All teams were also required to rationalize the bioethical implications of using the CRISPR‐cas system in their system of choice. 55.56% of the students could effectively describe the bioethical implications of using the technology in their system. Notably, only one team proposed a strategy to modify a gene in human embryos, while all other teams chose either human somatic cells or other organisms. Considering the required bioethical component of this proposal, this likely signifies that students may be unwilling to engage in such controversial dialog. In anything, student resistance highlights a need for bioethical training, even at the undergraduate level.

Student proposed CRISPR‐cas target genes and strategies in research proposal

In the 400‐level advanced genetics course, students worked in groups to create a podcast for the general topic focused on a theme of CRISPR‐cas technology. We chose to create podcasts over research proposals for two main reasons. Firstly, one of the course goals was to develop student communication skills, and secondly, this exercise was used intentionally in the first weeks of Advanced Genetics as an introduction into the rest of course material focusing on current findings and applications of CRISPR‐cas technology through primary literature. The three topics chosen for each group's podcast included: (a) CRISPR‐cas history, guidelines, and treatment of disease; (b) CRISPR‐cas gene editing in human embryos and live humans; and (c) CRISPR‐cas agriculture and food. (Rubric for the podcast, Table S4 ). When assessed for content and depth of knowledge, student work again demonstrated that fundamental aspects of CRISPR‐mediated gene edits were being understood by students (data not shown). Again, these data signify that learning modules such as the one herein is an effective and engaging means to teach these concepts to undergraduates.

3.2. Case‐based learning modules as gateway into authentic research practices

Bringing CRISPR‐cas9 technology to undergraduate curriculum can prove challenging especially in circumstances where resources or instructor familiarity might be limiting factors. Although hands‐on experimentation with CRISPR systems is not feasible for every institute, we tested whether a case‐based learning module is sufficient to teach students about the effective use of CRISPR‐cas technology in authentic research. We asked students to report the effectiveness of using CRISPR‐cas technology in (a) learning how authentic biology research is conducted, and (b) their abilities to apply tools learnt in experimental research and design ( Figure S2a,b ). The majority of students who did not see the importance of these examples before engaging in the exercise could clearly see the relevance upon completion of the module. These data suggest that students found they could apply this case‐based module to authentic practices in the research process.

Although this module is mainly computer‐based, the manipulation of gene sequences using basic molecular biology software (SnapGene) proved to be valuable to the student learning experience. Recent findings have shown that computer‐based undergraduate research experiences in lab courses produce similar learning outcomes and higher sense of achievement and satisfaction as bench‐based lab experiences. 47 This suggests computer‐based lab experiences can have positive effects on students' mindset.

Anecdotally, students have difficulty visualizing the design, implementation and expected results of manipulating sequences. Here we took a backwards design approach, working from affected protein produced from CRISPR‐cas‐based edits to the unmodified CCR5 gene for students to the visualize how their desired outcome necessitate thinking critically about each process of the central dogma. This technical design can be done without the use of sequencing computer software; however, we find that the use of SnapGene (or similar software) is helpful in allowing students to conceptualize how changes at the genomic level affect the gene product. When asked students for written anonymous feedback about the use of SnapGene to support our lab learning outcomes, students commented on the effectiveness of visualizing nucleotides, amino acids and features easily. Additionally, the ability to make desired nucleotide changes to simulate gene edits/modification was beneficial. A few students did comment on the challenges of learning how to use the program initially, but that with practice they were able to use the program more effectively. We should also note that student understanding seemed to be drastically improved when they could visualize both strands of the DNA and its polarity, not just coding strand of the desired target.

3.3. Beyond case‐based learning modules—Expanding into other high impact practices

In the future, we can imagine instructors expanding this case‐based learning module focused on CCR5 into other areas of biology and medicine. For example, bringing into class a published example where students can analyze data from an individual with HIV and leukemia was given a stem‐cell transplant from a donor homozygous for CCR5 Δ32. 48 As a result, genotyping and phenotypic analysis revealed the individual had switched to homozygous Δ32 genotype and was cured of HIV and leukemia and HIV. This allows for deeper discussions into experimental data that probes the relationship between genotypes and phenotypes.

In our iteration of this module in Advanced Genetics, complementing this exercise with primary literature led us to analyze and discuss methodology and data of two scientific papers. The first paper was used as a historical perspective of what had been done previously in the field using Zinc Finger Nucleases to genetically modify T cells of individuals to Δ32 version and then transplant back into an individual (autologous transplantation). 49 As a class we identified the Zinc Finger Nuclease target sites within the CCR5 gene. The second paper was used to discuss how scientists have used CRISPR‐cas9 technology to create indels in CCR5 of T cells through NHEJ and test its effect on HIV infection. 50 Following the focus on CCR5 , we went on to study the recent work on gene editing of dystrophin gene in muscle dystrophy in dogs, and continued to use SnapGene to analyze CRISPR genes.

This module can also be used as a framework to create additional case‐based learning studies for different diseases that are currently being targeted with somatic, non‐heritable/germline CRISPR‐cas technology. For example, currently the first human clinical trial utilizing CRISPR technology for immunotherapy cancer treatment is underway at University of Pennsylvania by removing individual T cells, modifying genes of T cells in lab, and then putting back the modified T cells into individuals to attack cancer cells. 51 , 52 Other current examples include, companies working to modify the BCL11A gene and beta‐globin gene to treat inherited blood disorders beta thalassemia and, sickle‐cell disease 53 , 54 , 55 (Vertex, Editas, Sanford University). These “ex vivo” methodologies involve a different set of considerations, both from the scientific and ethical perspectives. A notable case is the first human in vivo CRISPR editing clinical trial called EDIT‐101 at the genome editing company Editas. Editas has received FDA approval for utilizing CRISPR technology to modify the CEP290 gene in photoreceptor cells to treat retinal degeneration condition called Leber Congenital Amaurosis 10. 56 , 57 , 58 The methodology differs here because scientists will use CRISPR technology and adeno‐associated viral (AAV) delivery system to deliver CRISPR components to edit genes inside the human body in vivo rather than ex vivo. Collectively, these different studies and clinical trials can be used to immerse students in analyzing biomedically relevant genes and associated diseases in the classroom, and bring forward the discussion on how both non‐heritable and heritable CRISPR gene editing is being designed and applied in basic science and medicine.

CONFLICT OF INTEREST

The authors declare no potential conflict of interest.

Supporting information

Appendix S1 . Instructor guide/key.

Appendix S2 . Student worksheet.

Appendix S3 . Figures S1, S2 and Tables S1 to S5.

ACKNOWLEDGMENTS

This exercise was conducted in Spring 2019 Genetics and Advanced Genetics course at Stetson University. The authors appreciate the efforts of the students. Funding for SnapGene Software for student use was supplied by the Stetson University Biology Department. This research was supported by National Science Foundation Grant DBI‐1346549 to Emory University. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the authors and do not necessarily reflect the views of the National Science Foundation or Emory University. The Institutional Review Board protocol number for the Genetics courses at Stetson University is 335 (PI:Lynn Kee).

Pieczynski JN, Kee HL. “ Designer babies ?!” A CRISPR‐based learning module for undergraduates built around the CCR5 gene . Biochem Mol Biol Educ . 2021; 49 :80–93. 10.1002/bmb.21395 [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]

Funding information National Science Foundation, Grant/Award Number: DBI‐1346549; Stetson University Biology Department

Contributor Information

Jay N. Pieczynski, Email: ude.snillor@iksnyzceipj .

Hooi Lynn Kee, Email: ude.nostets@eekh .

Ethics of Designer Babies

A designer baby is a baby genetically engineered in vitro for specially selected traits, which can vary from lowered disease-risk to gender selection. Before the advent of genetic engineering and in vitro fertilization (IVF), designer babies were primarily a science fiction concept. However, the rapid advancement of technology before and after the turn of the twenty-first century makes designer babies an increasingly real possibility. As a result, designer babies have become an important topic in bioethical debates, and in 2004 the term “designer baby” even became an official entry in the Oxford English Dictionary . Designer babies represent an area within embryology that has not yet become a practical reality, but nonetheless draws out ethical concerns about whether or not it will become necessary to implement limitations regarding designer babies in the future.

The prospect of engineering a child with specific traits is not far-fetched. IVF has become an increasingly common procedure to help couples with infertility problems conceive children, and the practice of IVF confers the ability to pre-select embryos before implantation. For example, preimplantation genetic diagnosis (PGD) allows viable embryos to be screened for various genetic traits, such as sex-linked diseases, before implanting them in the mother. Through PGD, physicians can select embryos that are not predisposed to certain genetic conditions. For this reason, PGD is commonly used in medicine when parents carry genes that place their children at risk for serious diseases such as cystic fibrosis or sickle cell anemia. Present technological capabilities point to PGD as the likely method for selecting traits, since scientists have not established a reliable means of in vivo embryonic gene selection.

An early and well-known case of gender selection took place in 1996 when Monique and Scott Collins saw doctors at the Genetics & IVF Institute in Fairfax, Virginia, for in vitro fertilization. The Collins’ intended to conceive a girl, as their first two children were boys and the couple wanted a daughter in the family. This was one of the first highly publicized instances of PGD in which the selection of the embryo was not performed to address a specific medical condition, but to fulfill the parents’ desire to create a more balanced family. The Collins’ decision to have a “designer baby” by choosing the sex of their child entered the public vernacular when they were featured in Time Magazine’s 1999 article "Designer Babies". Though the Collins’ case only involved choice of gender, it raised the issues of selection for other traits such as eye color, hair color, athleticism, or height that are not generally related to the health of the child.

Prior to the Collins’ decision to choose the sex of their child, The Council on Ethical and Judicial Affairs released a statement in 1994 in support of using genetic selection as a means to prevent, cure or specific diseases, but that selection based on benign characteristics was not ethical. Some ethical concerns held by opponents of designer babies are related to the social implications of creating children with preferred traits. The social argument against designer babies is that if this technology becomes a realistic and accessible medical practice, then it would create a division between those that can afford the service and those that cannot. Therefore, the wealthy would be able to afford the selection of desirable traits in their offspring, while those of lower socioeconomic standing would not be able to access the same options. As a result, economic divisions may grow into genetic divisions, with social distinctions delineating enhanced individuals from unenhanced individuals. For example, the science-fiction film Gattaca explores this issue by depicting a world in which only genetically-modified individuals can engage in the upper echelon of society.

Other bioethicists have argued that parents have a right to prenatal autonomy, which grants them the right to decide the fate of their children. George Annas, chair of the Department of Health Law, Bioethics, and Human Rights at Harvard University has offered support for the idea of PGD, and the designer babies that result, as a consumer product that should be open to the forces of market regulation. Additionally, other arguments in favor of designer baby technologies suggest that parents already possess a high degree of control over the outcome of their children’s lives in the form of environmental choices, and that this should absolve some of the ethical concerns facing genetic selection. For example, parents keen on establishing musical appreciation in their children may sign them up for music classes or take them to concerts on a regular basis. These choices affect the way a child matures, much like the decision to select certain genes predisposes a child to develop in ways that the parents have predetermined are desirable.

The increased ability to control and manipulate embryos presents many possibilities for improving the health of children through prenatal diagnosis, but these possibilities are coupled with potential social repercussions that could have negative consequences in the future. Ultimately, designer babies represent great potential in the field of medicine and scientific research, but there remain many ethical questions that need to be addressed.

• Agar, Nicholas. American Institute of Biological Sciences. “Designer Babies: Ethical Considerations,” http://www.actionbioscience.org/biotech/agar.html (Accessed October 16, 2010).
• Annas, George. “Noninvasive Prenatal Diagnostic Technology: Medical, Market, or Regulatory Model?” Annals of the New York Academy of Sciences 721 (1994): 262–8.
• Council on Ethical and Judicial Affairs, American Medical Association. “Ethical Issues Related to Prenatal Genetic Testing,” Archives of Family Medicine 3 (1994): 633–42.
• Kitcher, Philip. “Creating Perfect People.” In Companion to Genetics , eds. Justine Burley and John Harris, 229–42. Boston: Blackwell Publishing, 2004.
• Lemonick, Michael. “Designer Babies.” 153, Time Magazine, January 11, 1999.
• Morales, Tatiana. CBS News. “Choosing Your Baby’s Gender.” http://www.cbsnews.com/stories/2002/11/06/earlyshow/contributors/emilysenay/main528404.shtml (Accessed October 17, 2010).
• Verlinsky, Yuri. “Designing Babies: What the Future Holds,” Reproductive BioMedicine Online 10 (2005): 24–6.

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Q&A: Are designer babies our brave new future? A geneticist explains what’s at stake

(NIH Image Gallery via Flickr)

Last November, Chinese scientist Dr. He Jiankui announced the birth of the first two genetically modified humans — twin girls named Nana and Lulu, whom he helped create using gene editing technology. This method of “gene surgery,” as he described it in his announcement on YouTube , is widely used in research and certain clinical settings around the world. But ethical concerns have kept scientists from using the technique to create living, breathing, genetically modified humans — until now.

The technology He used is called CRISPR , which can be thought of as a find-and-replace tool on your computer: It searches through the entire genome and helps researchers modify DNA at specific locations through gene-editing proteins. Dr. He intended to introduce a genetic change that would make the children resistant to HIV, though other scientists have yet to verify whether or not this change worked, or worked safely. He’s controversial experiment triggered outrage in the genetics community and led to leaders in the field calling for a moratorium on germline editing, or creating DNA edits that will be passed on to an individual’s descendants.

I recently spoke to Dr. Mazhar Adli, a researcher at the University of Virginia whose laboratory utilizes and develops CRISPR-based gene editing techniques. We discussed the ethics and the future of genome editing now that the first genetically modified babies have arrived. The following interview has been edited for clarity and brevity. 

Alexandra Demetriou: The current controversy is about putting a moratorium on what scientists call “germline editing.” Can you explain how germline editing is different from somatic gene editing, in which scientists edit cells not involved in reproduction?

Mazhar Adli: The difference between germline and somatic cell editing is that when you edit somatic cells, any change you make stays just with that individual and will not be passed on to the next generation. However, if you do germline editing, that means that every cell in that body is going to be edited, including the germ cells which transfer that genetic material to the next generation. Therefore you are not only changing that person, you are also changing any offspring from that individual, and since it is a genetic change it will go forever. That is the biggest ethical dilemma: You are changing something in an embryo, which can’t give consent, and you are also changing any offspring that will oneday come from that embryo. It has much larger-scale implications.

AD: Back in 2017 there was a big story in the news where an American doctor edited out a human heart defect in embryos. Is that a similar situation? 

MA: It is a similar situation, but the American doctor did it solely as an experiment and didn’t let that embryo develop into a baby. Dr. He, on the other hand, implanted edited embryos into the mother’s womb, and those embryos developed into babies that were born. So that’s the big difference — stem cell research and embryonic research is allowed in the U.S. as long as you don’t implant the embryo.

AD: What kind of health risks could those gene-edited babies then face in their adult life?

MA: The short answer is that we don’t know. We have no idea what’s going to happen to these babies once they develop into adulthood, because we have never done these experiments before. It’s completely unknown to us. That’s the scary part, right? Because let’s say there are major side effects. Who is going to take responsibility? Is it going to be the parents? Is it going to be the scientist who’s done it? And beyond that, what can you do about it once that person has grown up and is suffering from a side effect you caused?

Dr. Mazhar Adli

AD: Do scientists actually know enough to make these designer babies now, or is that still far beyond today’s scientific knowledge?

MA: Certain things could be designed based on current knowledge, but there are many other biological traits that we can’t really pinpoint to a single gene and will take much longer to fully understand. For example, based on animal models we’ve found some of the genes that control simpler traits, like cholesterol levels or height. But there are certain biological traits that are more complicated, like IQ level. We’re still figuring out which genes, and how many different genes, contribute to complex traits like that. But a trait like muscle, for example, is much simpler and we could manipulate those genes to make an individual more or less muscular. Dr. He has basically created a designer baby. He manipulated a gene to make those individuals less susceptible to HIV virus infection. The trait is relatively simple, but he still is designing something.

AD: Do you think it’s inevitable that we will start to see more designer babies like this, if the technology is proven safe enough?

MA: Yes, I think it is inevitable. Our generation is going to see genetically modified humans walking around us. Indeed, there are basically already genetically edited humans walking among us. Take, for example, the three-parent babies that come from mitochondrial transplantation. There are many such cases, and these humans are healthy and walking among us. The United States initially allowed mitochondrial transplantation, but later banned it. But in 2016 for example, an American couple that wanted mitochondrial replacement therapy just flew their U.S. doctor to Mexico and had the operation done there instead. So in a way, once you have these opportunities, you cannot fully close the door on them.

AD: So the only way to prevent it would be an international law, right?

MA: An international law that can be enforced and supported by a government-level agreement on these things. If it’s not enforced, it’s only going to be some media statement from scientists. Currently, almost all scientists agree that we shouldn’t be trying to create designer babies. But if there’s even one rogue scientist who decides to do it, and there is no institution or political entity that can enforce the laws, then how can we prevent it from happening?

AD: Current scientists are proposing a moratorium on genetically editing germline cells. Do you think it will be beneficial or do you think it might impede research in the long run?

MA: We need to carefully frame the moratorium so the research and development aspect is not affected, and only germline editing is prevented. And I think the public and the media really need to be engaged in this discussion. This is an impressive technology that has the potential to help cure many genetic diseases, so we should be very careful to not pump fear into the public because if this happens, there will then be a general lack of societal acceptance.

I liken this to the rise of in vitro fertilization. The first IVF baby was born in 1978, and initially it was all over the headlines and there was a big fear that doctors and scientists were creating some kind of monster. But now IVF is a routine thing — there are 18-20 million babies born through IVF walking among us — and the public has accepted it. I think genome editing probably will have a similar thing that many babies will hopefully be cured through genome editing. But we must move forward carefully and engage the public in the ethical debate.

Correction: An earlier version of this post incorrectly stated that Dr. Adli is a researcher at the University of North Carolina at Chapel Hill. Adli obtained his Ph.D. there but is now at the University of Virginia.

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July 12, 2021

A New Era of Designer Babies May Be Based on Overhyped Science

Genetic testing with IVF is being marketed as a means to choose a healthy embryo, despite questions about the soundness of the technology

By Laura Hercher

Christopher Burgstedt Getty Images

For better or worse, genetic testing of embryos offers a potential gateway into a new era of human control over reproduction. Couples at risk of having a child with a severe or life-limiting disease such as cystic fibrosis or Duchenne muscular dystrophy have used preimplantation genetic testing (PGT) for decades to select among embryos created through in vitro fertilization (IVF) for those that do not carry the disease-causing gene. But what new iteration of genetic testing could tempt healthy, fertile couples to reject our traditional time-tested and wildly popular process of baby making in favor of hormone shots, egg extractions and DNA analysis?

A California-based start-up called Orchid Biosciences claims it has an answer to that question. The company offers prospective parents genetic testing prior to conception to calculate risk scores estimating their own likelihood of confronting common illnesses such as heart disease, diabetes, and schizophrenia and the likelihood that they will pass such risks along to a future child. Parents-to-be can then use IVF, along with Orchid’s upcoming embryo screening package, to identify the healthiest of their embryos for a pregnancy.

Orchid aims to use PGT and IVF to expand what is already a thriving marketplace in screening tests for prospective parents. Initially, the only people offered tests to prevent genetic disease in the next generation were those whose ancestry put them at higher risk for a specific condition, such as Tay-Sachs disease in the Ashkenazi Jewish population. The first genetic screen intended for universal use and covering a wide range of diseases was introduced by Counsyl (now part of Myriad Genetics) in 2010. Today carrier screening is a $1.7-billion industry. These tests search for genetic problems that otherwise come to light only after the birth of an affected child. But diseases caused by a single gene are rare. Most children are born healthy, and most couples who do carrier screening come away reassured.

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By contrast, Orchid’s risk assessment includes common diseases, ensuring that a high percentage of prospective parents who do this version of preconception testing will find something to worry about. Those who choose to act on their concerns will soon have the option of paying for IVF plus Orchid’s embryo-testing package. According to its promotional materials, the company will provide a scorecard intended to identify, among various embryos, the future children least likely to develop heart disease, breast cancer, prostate cancer, type 1 or 2 diabetes, and five other conditions that make up Orchid’s current common disease risk portfolio.

With a marketing strategy that encourages routine use of IVF for those who can afford it, Orchid breaks new ground in introducing the first—but likely not the last—consumer-driven model of human reproduction. The ambitions of this new Silicon Valley venture into health care are backed by the imprimatur of health-tech luminaries, including 23andMe co-founder and Orchid investor Anne Wojcicki. Orchid’s first product on the market is its “Couple Report,” at a cost of  $1,100. Phase two, scheduled for launch later this year, examines embryos conceived by IVF, allowing the couple to pick and choose among potential children in a process that Orchid CEO Noor Siddiqui, speaking in an interview on the podcast Mendelspod in April, referred to as “embryo prioritization.” Siddiqui is a former Thiel Foundation Fellow whose interests lie in the use of technology in medicine. She did not respond to repeated requests for an interview from Scientific American .

Geneticists have greeted Orchid’s launch with skepticism, in large part because of objections to the company’s use of a technique called polygenic risk scores to assess an embryo’s lifetime risk of common diseases. Heart disease runs in families just like musical ability or height, but only in exceptional cases can the inherited risk be traced to a single gene. Hundreds or even thousands of genes each contribute in a small way. Polygenic risk scores attempt to sum up the overall likelihood of a particular outcome—such as getting a disease—by simply observing which patterns of variation in a genome are associated with a higher or lower probability of having the condition. In other words, this method gives us information about who might be more or less likely to get sick without explaining why. The statistical association is real but hardly definitive, and it tracks population-level trends that may not be relevant for the individual in question.

Researchers who work with polygenic risk scores are concerned about their use in this context. “We don’t know what these variants are doing biologically,” says Peter Kraft, a professor of epidemiology and biostatistics at the Harvard T. H. Chan School of Public Health. “Something that’s associated with a decreased risk of breast cancer could be associated with all other kinds of things, some of which might actually increase your risk of something else. We just don’t know enough yet.”

Some version of prenatal planning as envisioned by Orchid may be possible eventually, but few experts seem to share their optimism that today is that day. A July 1 special report in the New England Journal of Medicine pointed out the inherent weakness of using polygenic risk scores to distinguish among sibling embryos—which, unlike random individuals in a population, will be identical in 50 percent of the genetic variation that is examined to generate a score. The report concluded with recommendations on how to convey any purported benefits from polygenic scores in embryo selection responsibly—and the need to emphasize the underlying uncertainties in the data. “Any one of the issues discussed in this article would be difficult to communicate accurately—even to other scientists and clinicians,” the authors noted. “Collectively, these issues constitute a formidable challenge for [companies selling these services], which must ensure that their customers understand what they are doing.” The report also called for the Federal Trade Commission to look carefully at claims made by any company using polygenic scoring to pick embryos.

Current polygenic risk scores have limited predictive strength and reflect the shortcomings of genetic databases, which are overwhelmingly Eurocentric. Alicia Martin, an instructor at Massachusetts General Hospital and the Broad Institute of the Massachusetts Institute of Technology and Harvard University, says her research examining polygenic risk scores suggests “they don’t transfer well to other populations that have been understudied.” In fact, the National Institutes of Health announced in mid-June that it will be giving out $38 million in grants over five years to find ways to enhance disease prediction in diverse populations using polygenic risk scores. Speaking of Orchid, Martin says, “I think it is premature to try to roll this out.”

In an interview about embryo screening and ethics featured on the company’s Web site, Jonathan Anomaly, a University of Pennsylvania bioethicist, suggested the current biases are a problem to be solved by getting customers and doing the testing. “As I understand it,” he said, “Orchid is actively building statistical models to improve ancestry adaptation and adjustments for genetic risk scores , which will increase accessibility of the product to all individuals.”

Still, better data sets will not allay all concerns about embryo selection. The combined expense of testing and IVF means that unequal access to these technologies will continue to be an issue. In her Mendelspod interview, Siddiqui insisted, “We think that everyone who wants to have a baby should be able to, and we want our technology to be as accessible to everyone who wants it,” adding that the lack of insurance coverage for IVF is a major problem that needs to be addressed in the U.S.

But should insurance companies pay for fertile couples to embryo-shop? This issue is complicated, especially in light of the fact that polygenic risk scores can generate predictions for more than just heart disease and cancer. They can be devised for any trait with a heritable component, and existing models offer predictions for educational attainment, neuroticism and same-sex sexual behavior, all with the same caveats and limitations as Orchid’s current tests for major diseases. To be clear, tests for these behavioral traits are not part of Orchid’s current genetic panel. But when talking about tests the company does offer, Siddiqui suggested that the ultimate decision makers should be the parents-to-be. “I think at the end of the day, you have to respect patient autonomy,” she said.

Despite Orchid’s hard lean into parental free choice, bioethicists such as Gabriel Lázaro-Muñoz of the Center for Medical Ethics and Health Policy at Baylor College of Medicine worry that Orchid’s system of ranking embryos may unduly influence prospective parents and replace a very necessary broader societal debate on what qualifies as a good life. It is problematic for that reason, according to Lázaro-Muñoz, to have these companies “bias the conversation.”

Lurking in the background of every discussion on embryo selection and ethics is the specter of eugenics. “I think we have to be very aware of our history,” Lázaro-Muñoz says, “in terms of sterilization and state-mandated programs in the past that were aimed at ... exterminating individuals with some of these conditions.”

Clearly Orchid anticipates pushback. The company’s promotional materials include guides to fertility planning and the genetics of irritable bowel disease but also a set of talking points for  concerned relatives described as “ How to respond to your family skeptics —playing God, designer babies, and genetic enhancement.”

“Yes, we’re going there,” the guide says. Ethics? Bring it on. This is not a company in a defensive crouch. The “Our Principles” section of its Web site positions genetic testing as a human right. “From a reproductive freedom perspective, we stand for a couple’s right to have access to information that enables them to mitigate disease risk for their future child,” it says. Like other Silicon Valley health care technology pioneers, Orchid presents itself less as a product than as a social justice movement with a little commercial venture on the side, like a gift shop.

Orchid dismisses suggestions from detractors that its marketing oversells what polygenic risk scores have to offer in the context of screening embryos. “Parents are asking for this information and deserve to know it,” Siddiqui told Mendelspod, warning that those who stand in the way are “frankly being a little bit paternalistic.” And if prospective parents are not asking, Siddiqui suggested, perhaps they should be. When it comes to the next generation, “we’ve been sort of just rolling the dice,” Siddiqui said, while “the ability to actually stack the odds against disease is ... sort of a new capability that humanity has just gotten online.”

The suggestion that embryo selection is not only something people can do but something they should do raises perhaps one of the thorniest ethical issues of all. In the Mendelspod interview, Siddiqui drew a contrast between “earned” and “unearned” bad luck. “You can get hit by a car, right? That’s totally out of your control. But what is earned bad luck?” she asked before answering her own question. “I mean, that’s the idea of … you’re going base jumping constantly, and then you break your leg…. You kind of exposed yourself to higher risk there.”

Ultimately, if technology allows Orchid to offer a product that meaningfully reduces the risk of disease susceptibility in the next generation, does that mean that anyone who can’t or won’t use it deserves their bad luck? If the basic, no-frills version of human reproduction comes to be seen as a form of careless parenting, it invites a callous parsing of who does and does not deserve their fate—and, by extension, who does and does not deserve resources and support.

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Designer Babies: Revealing the Ethical and Social Implications of Genetic Engineering in Human Embryos

2023, International Journal of Science and Research

The idea of "designer babies" was born as a result of advances in genetic engineering, which made it possible to create and modify the genetic makeup of human embryos. The advent of CRISPR-Cas9 technology revolutionized genetic editing, offering scientists a more efficient way to target specific genes and make modifications compared to previous methods. This breakthrough, combined with pre-implantation genetic diagnosis (PGD) and in vitro fertilization (IVF), has opened up possibilities for advancements in the field of designer babies. However, it is crucial to recognize that genetic engineering is still evolving and numerous technical, ethical, and safety challenges must be addressed before designer babies can become a commonplace practice. This article highlights the ethical considerations involved in using CRISPR-Cas9, PGD, and IVF in the pursuit of designer babies and regulatory frameworks and policy considerations surrounding these reproductive techniques. It also acknowledges the potential benefits, such as the prevention of genetic diseases, but underscores the significance of responsible research and regulation to ensure that these technologies are employed ethically and in line with societal values.

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Bioethics Observatory - Life Sciences Institute - Catholic University of Valencia (Spain) , Manuel Zunín , Justo Aznar

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ABHIJIT MITRA , Pritam Mukherjee

With the advent of scientific and technological advancements in the field of human health and medicine, genetic engineering especially genome mapping, sequencing and editing are well within the grasp of the scientific community. Now have disposal powerful tools of Molecular biology, Bioinformatics and Biotechnology to create 'Designer Babies'. 'Designer Babies' as the name suggests are genetically tailor-made embryos, wherein desired traits can be identified in pre-implantation diagnosis by screening with gene-specific markers. These markers can identify disease linked gene(s) and non-disease specific gene(s). Also theoretically, gene editing albeit highly controversial and debatable can also be employed to effectively and efficiently edit the genome of 'Designer Babies' to accent special traits and characteristics e.g. viral resistance in the current scenario of Covid-19 pandemic. The pros and cons of this modus operandi remain contentious and ambivalent to say the least. This article takes a look at the history, frontier research and also the ethical dilemma leading to advancements in genetic research and their application under the commercialized banner of 'Designer Babies'.

Julian Savulescu , Tom Douglas , Jonathan Pugh , Christopher Gyngell

Palgrave Communications

Michael Morrison

Following the birth in 2018 of two babies from embryos altered using CRISPR-Cas9, human germline gene editing (GGE) moved from abstract concern to reality. He Jiankui, the scientist responsible, has been roundly condemned by most scientific, legal and ethical commentators. However, opinions remain divided on whether GGE could be acceptably used in the future, and how, or if it should be prohibited entirely. The many reviews, summits, positions statements and high-level meetings that have accompanied the emergence of CRISPR technology acknowledge this, calling for greater public engagement to help reach a consensus on how to proceed. These calls are laudable but far from unproblematic. Consensus is not only hugely challenging to reach, but difficult to measure and to know when it might be achieved. Engagement is clearly desirable, but engagement strategies need to avoid the limitations of previous encounters between publics and biotechnology. Here we set CRISPR in the context of the biotechnology and fertility industries to illustrate the lessons to be learned. In particular we demonstrate the importance of avoiding a 'deficit mode' in which resistance is attributed to a lack of public understanding of science, addressing the separation of technical safety criteria from ethical and social matters, and ensuring the scope of the debate includes the political-economic context in which science is conducted and new products and services are brought to market. Through this history, we draw on Mary Douglas' classic anthropological notion of 'matter out of place' to explain why biotechnologies evoke feelings of unease and anxiety, and recommend this as a model for rehabilitating lay apprehension about novel biological technologies as legitimate matters of concern in future engagement exercises about GGE.

Maurizio Balistreri

In the future human reproduction could radically change. Today the birth occurs always through the fertilisation of an egg cell by the spermatozoon: tomorrow people could be born by cloning from a somatic cell or by parthenogenesis, without the need for a spermatozoon. Moreover, for the moment pregnancy may only occur in the woman's body: yet in the future, we could also have artificial wombs able to grow an embryo up to the birth. Finally, today our genetic heritage is determined by chance, while in the future we could choose our children's DNA: at that point, we could not only correct important anomalies, but even enhance the future generations' dispositions and capacities. New reproductive technologies like cloning, parthenogenesis, artificial gametes and genome editing may contribute to correcting some important natural injustices. At the same time, we must also be aware that introducing new reproductive technologies may increase social injustice and negatively affect our 'reproductive freedom'. In the future human reproduction could radically change. Until about forty years ago, birth was only possible via a sexual relationship: then in 1978 children started to be born not only sexually, but also with assisted reproduction. Now, it does not matter which technique is used: the birth of a new person occurs always

Bella Ratner

As the science related to genetic engineering becomes more advanced, more and more ethical questions relating to technologies such as CRISPR and preimplantation genetic diagnosis (PGD) arise. If we have the opportunity to choose the genes of our future children in order have children with our desired characteristics, should we do so? Is it okay to mess with some genes of your future child and not others? In this paper, I discuss arguments and objections associated with these questions. The aim of this paper is to show that it is ethical to alter the DNA of your future child or select a specific child only when you are attempting to improve the health of that child. Many might find the possibility of designing their own baby exciting. What could be better than creating the exact baby that you have always dreamed of? While it is easy to fantasize about the positives of genetic engineering, when we really dig deep into what such technology would mean for society, many problems emerge. ...

Thaissa lima

A look into genetical engineered babies and it ethical concerns

Accountability in Research

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The Case of the Designer Baby

I have recently been working on a bioethics textbook. Bioethics is a discipline largely driven by case studies – short narratives intended to make the ethical issues under discussion clear, real and urgent. Consequently, many bioethics textbooks include case studies. I want to do something different in this month’s column, namely, present one of the case studies on which I have been working. Attentive readers will notice that the case study presented below gets at the same issues I considered in last month’s column (CRISPR and the genetic revolution). I would like readers to think not only about the issues raised by the case itself, but also about whether or not the case study helps to make the ethical issues raised by these technologies clearer and more accessible.

The development of new technologies like CRISPR are likely to make it possible to alter the human genome in ways that will affect future generations – that is to say, genetic alterations that are made in particular individuals will then be passed on to their descendants. Moreover, while these changes are likely to occur as a result of particular parents making changes in the genomes of their children rather than as a result of government interventions, the long-term consequences may alter not only individual genomes but the human genome as well. This case study is set at a time in the future in which this technology has become both commonplace and commercialized.

J oe and Susan desperately want to have a family, and they both want children who are genetically related to both of them. Unfortunately, they are both carriers of undesirable genetic conditions that are likely to affect the health of their children. They do not want any potential children to suffer, so they have, so far, chosen not to reproduce.

Joe and Susan have been inundated with ads from CRISPR Services lately, and they are intrigued by their promise. ‘Do you have a family history of Huntington’s Disease or cystic fibrosis? Tay -Sachs or sickle cell anemia? Dementia or cancer? Come and see us, and we’ll make sure that your children are born disease-free, and that your descendants will not be afflicted by the family curse!’ The clinic offers IVF treatments, and then uses gene editing technology on the resulting embryos to ensure that any that are implanted will produce healthy offspring.

Joe and Susan feel that this is the answer to their prayers: they both really want a family, but were afraid to have children who were sick and suffering. Now, they feel that their dreams have come true. They quickly make an appointment with the clinic director, who assures them that the gene editing necessary to ensure that their future children will be healthy is safe, simple, and accurate. He also hands them a pamphlet detailing the clinic’s services. The bronze package will ensure that their children are disease-free; the silver package will allow these disease-eliminating alterations to be passed on to their descendants; the gold package offers additional changes, such as the elimination of undesirable traits (like a tendency to be obese or shy) and the addition of desirable ones (such as athletic ability and enhanced intelligence); the platinum package allows future generations to also receive the enhancements chosen for the child. The gold and platinum packages have a check list of traits to eliminate and enhance, and the cost, of course, goes up the more options the customer chooses.

‘I’ve always wanted a kid that I could play basketball with,’ says Joe. ‘And could you imagine if we had a child who is both athletic and mathematically brilliant? We’d never have to pay for university!’ ‘It would be such a relief to have kids who are disease-free,’ notes Susan. ‘No worries about dementia, no risk of Huntington’s.’

‘We could have healthy kids who are geniuses as well as empathetic and kind,’ adds Joe. ‘I didn’t know that was even possible, but look at all these options! Who wouldn’t want all these things for their kids?’

Joe and Susan spend a few minutes perusing the list of desirable traits that they could select, and undesirable traits that they could eliminate. Finally, though, they have to come to a decision.

Should they add these desirable traits to their future children, as well as ensuring that they are born healthy? Should they delete traits that are undesirable, but not health-related? If they decide to go ahead with these design modifications, should they stop at the Gold package, or go all out, and choose the Platinum one?”

Readers, I encourage you to think about how you would answer these questions.

Featured image: Designer Baby store, Hackney, London, sludgegulper , CC BY-SA 2.0 , via Wikimedia Commons.

Wolfville native Rachel Haliburton teaches philosophy at the University of Sudbury. Her latest book, The Ethical Detective: Moral Philosophy and Detective Fiction , was published in February by Lexington Books.

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Home → Features → Natural Sciences → Biology → Genetics

What are designer babies — a healthcare wonder or an ethical horror?

Designer babies aren't coming -- they're already here.

The very first designer baby was Adam Nash. Born in the 2000s, Nash was ‘designed’ in a petri dish in a lab to save his sister. His sister was born with Fanconi anemia , a rare and dangerous genetic disease that required a donor for her stem cell therapy. The solution devised by the parents and doctors was to conceive Nash so that the umbilical cord blood containing stem cells could be utilized to treat his sister.

During his in vitro conception, Adam was screened to make sure he didn’t have the disease and could serve as a donor. The plan worked, and Adam saved his sister, becoming the world’s first designer baby in the process. But what exactly are designer babies ?

The term refers to an in vitro , genetically ‘designed’ baby. Genetic methods are employed to modify or alter certain genes in the baby’s genome, most often to avoid disease, but the method can in theory also be used to favor some traits like intelligence, height, gender selection, etc.

Before advancements in the fields of in vitro fertilization and genetic engineering, designer babies were considered little more than a sci-fi project. But rapid progress brought them into reality and by the early 2000s, designer babies started to trigger spirited debates regarding both the biology and the ethics of the practice.

It’s already happening

In one sense, genetically modifying a child with particular traits is already done on a fairly large scale. Couples with infertility problems have long been utilizing IVF technology to conceive, and one of the perks of IVF is screening and selection of the desired embryo prior to implantation.

For instance, pre-implantation genetic diagnosis (PGD) is employed to screen embryos for multiple genetic characteristics before their implantation in the mother. PGD can show whether the embryo carries genes responsible for conditions like sickle cell anemia and cystic fibrosis . PGD is nowadays considered a reliable method for the selection of traits.

But there’s another side to the prospect of genetically engineered IVF babies. As techniques become more advanced, they could entice would-be parents to engineer their babies. For instance, the gene-editing approach known as CRISPR-Cas9 can edit DNA with a single nucleotide precision utilizing a bacterial enzyme (Cas9). Thanks to CRISPR-Cas9 and other modern gene-editing technologies, we are now able to remove the mutated disease-causing genes – which might prove beneficial after a safety trial in humans. But going from that to actively trying to improve babies’ genetic material is just a step away.

The concept of Frankenstein’s monster still haunts people and many are against this procedure, fearing that it would lead to unnatural, engineered societies. There are strict legal restrictions on genetic alteration of the human genome in several countries. The medical research community has essentially banned the use of CRISPR-Cas9 in genome editing and human reproduction. But it’s still happening to some extent.

China has already been utilizing CRISPR-Cas9 to genetically alter unsustainable embryos. A developmental biologist of Francis Crick Institute, Kathy Niaken was granted authorization by Human Fertilization and Embryology Authority (HFEA) to analyze the challenges faced in early developmental stages resulting in miscarriages utilizing CRISPR-Cas9.

Germline editing

Germline engineering, the process by which the genome of an individual is edited in such a way that the change is heritable, is even more controversial.

Even in a medical context, genome editing is sometimes regarded with criticism. Peter Mills, an assistant director of the UK Nuffield Council on Bioethics, says that since the 1970s (when innovations in the field first emerged) there is an unchanged agreement that germline alterations are off-limits. Germ-line modifications are against human decency, says UNESCO’s lead.

Michael Sandel, a member of the US President’s Council on Bioethics says that altering germ-line cells jeopardizes the ‘code of giftedness’. According to him, when we acknowledge our children the way they are, we welcome them as gifts, not as any item of our desire or product of our ambition.

Sandel juxtaposes this idea of giftedness to a parenting style he calls “Hyper-parenting”, which overlooks the talents and desires of children while pushing the child to do what satisfies the ambitions and desires of the parents. A hyper-parent will force his child into playing sports and pursuing a top university, even as the child may want to be an artist or a musician or pursue a more laid-back university.

Now, one may wonder that what hyper-parenting has to do with genetic engineering. Many parents would presumably want to modify the genome of their offspring, but that doesn’t necessarily mean that they are hyper-parents. But some parents would be more inclined than others to “push” their child with every means possible.

A turning point for designer babies?

The next 40-50 years will show us the direction society is ready to take for gene editing in babies, but it won’t be an easy discussion. In the long run, if designer babies become widespread, it could be a social disaster, widening gaps between the rich and the poor to unprecedented levels as the rich are able to use the technique to their advantage while the poor will not.

However, germ-line engineering can be used to tackle social injustices, by offering kids from an underprivileged background a leg up. Like any other tool, gene editing is neither good nor bad by itself — it can be both good and bad depending on how it is used.

This leads us to the scorching ethical debate about what would constitute an acceptable edit. Tampering with the predisposition for genetic diseases is one thing, but what about other physical traits? Is making an embryo more predisposed to physical prowess acceptable? Where do you draw the line? There are few clear answers.

Apart from that, gene editing is a complicated, costly, and pretty dubious way to get what others have long gotten by other means, especially by selecting an embryo containing the gene of interest. Most things you can achieve using gene editing can also be achieved by embryo selection, argues Henry Greedy, a bioethicist of Stanford University. Instead of modifying the embryo, you

Ronald Green of Dartmouth College says that due to the anonymous health perils associated with genetic engineering and lack of public trust, he anticipates a slow down for CRISPR-Cas9 applications in the coming few decades, not only for disease prevention but also for designer babies.

Ultimately, despite so much technological progress, we’re still not sure how to deal with the prospect of designer babies. For now, the risks of gene editing seem to outweigh the benefits, especially when alternatives exist. But in the future, who knows.

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Case Study: Preimplantation Genetic Diagnosis and “Designer Babies”

Martha and Robert, a young couple, are both 26 years old. Both of them are also extremely short, Robert at 5’ 1†and Martha at 4’ 7â€. They each earned their college degrees in fields that are not science related, although they do know that genetics plays a large role in determining height. They both know first-hand that being short has its disadvantages, especially when it comes to sports and being ridiculed by your peers at an early age. Robert especially was targeted by bullies at a young age, and he spent many years overcoming the anger he felt growing up. Martha and Robert are ready to start a family but do not want their children to experience what it is like to be extremely short. They plan to try pre-implantation genetic diagnosis (PGD) using a genome wide association study to ensure that their offspring have a high probability of being tall. To achieve this, they will first do  in vitro  fertilization. Then, the genomes of each embryo will be screened for markers consistent with height, and only embryos likely to be tall will be implanted. Recent research using genome wide association studies has uncovered some of the genetics of tallness. The researchers grouped individuals into tall and short groups and then looked for genetic sequences shared by tall individuals that were not present in short individuals. The researchers found that height is controlled by at least 180 genes, and currently we do not have the technology to look at 180 genes in an embryo during preimplantation genetic diagnosis. Martha and Robert visit a fertility doctor and explain their intentions. The doctor tells them that the technology is not currently available but likely will be in the next 5 or 10 years, given the pace of advancement in DNA sequencing methods. Martha and Robert tell the doctor they are willing to wait. The doctor is uncomfortable, as PGD was developed to prevent transmission of fatal conditions, not for selection of what some would consider “vanity traitsâ€.

What would you do if you were the fertility doctor?

• Refuse to treat them. PGD is intended for use in cases of disease-risk. Choosing embryos based on predicted height is unethical and is a troubling step towards “designer babies”.
• Agree to treat them. Parents should be able ensure their children’s health and well being. PGD is safe, and there is no reason that a technology developed for one purpose can’t be used for another.

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Those designer babies everyone is freaking out about – it’s not likely to happen

Research Professor of Epidemiology, Emory University

Disclosure statement

A Cecile JW Janssens does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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When Adam Nash was still an embryo, living in a dish in the lab, scientists tested his DNA to make sure it was free of Fanconi anemia , the rare inherited blood disease from which his sister Molly suffered. They also checked his DNA for a marker that would reveal whether he shared the same tissue type. Molly needed a donor match for stem cell therapy, and her parents were determined to find one. Adam was conceived so the stem cells in his umbilical cord could be the lifesaving treatment for his sister.

Adam Nash is considered to be the first designer baby, born in 2000 using in vitro fertilizaton with pre-implantation genetic diagnosis, a technique used to choose desired characteristics. The media covered the story with empathy for the parents’ motives but not without reminding the reader that “eye color, athletic ability, beauty, intelligence, height, stopping a propensity towards obesity, guaranteeing freedom from certain mental and physical illnesses, all of these could in the future be available to parents deciding to have a designer baby. ”

The designer babies have thus been called the “future-we-should-not-want” for each new reproductive technology or intervention. But the babies never came and are nowhere close. I am not surprised.

I study the prediction of complex diseases and human traits that result from interactions between multiple genes and lifestyle factors. This research shows that geneticists cannot read the genetic code and know who will be above average in intelligence and athleticism. Such traits and diseases that result from multiple genes and lifestyle factors cannot be predicted using just DNA, and cannot be designed. Not now. And very unlikely ever.

Designer babies are next

The inevitable rise of designer babies was proclaimed in 1978 after the birth of Louise Brown, the first IVF baby, as the next step toward “a brave world where parents can select their child’s gender and traits .” The same situation occurred in 1994 when a 59-year-old British woman stretched the limits of nature by giving birth to twins using donated eggs that were implanted in her womb at a fertility clinic in Italy.

The response was the same in 1999 , when a fertility clinic in Fairfax, Virginia, offered sex selection of embryos to screen against diseases that only happen in boys. In 2013 , when 23andMe was granted a patent for a tool that predicts the likelihood of traits in babies based on DNA of two parents, the question of patenting designer babies was raised. In 2016 , when the U.K. permitted a woman to donate her healthy mitochondria to a couple using IVF to conceive a child, raising the number of parents to three , fears of unnatural children rose again. Last month , when Genomic Prediction, a New Jersey company, announced its DNA screening panel for embryos would also assess the risk for complex diseases such as Type 2 diabetes and heart disease that are caused by multiple genes, fears of engineering babies with high IQ or athletic prowess emerged.

The same issues arose on Nov. 26 when He Jiankui reported at the Second International Summit on Human Genome Editing in Hong Kong that he had successfully edited the DNA of twin baby girls born last month.

The designer baby doom scenarios have not evolved with the technology. It’s been the same story for decades. It’s the same “desirable” traits and the same assumption that parents want to select these traits if technology allowed. But no one seems to be questioning whether these traits are solely a product of our genes such that they can be selected or edited in embryos.

Wondering about designer babies was understandable in the early days, but repetition of these supposed fears now suggests lack of understanding of how DNA, and the genes they encode, work.

Designing favorable traits in babies is not simple

Although there are exceptions, DNA generally differs between people in two ways: There are DNA mutations and DNA variations.

Mutations cause rare diseases like Huntington’s disease and cystic fibrosis, which are caused by a single gene. Mutations in the BRCA genes substantially increase the risk of breast and ovarian cancer. Selecting embryos that do not have these mutations removes the entire or main cause of disease – women who don’t have BRCA mutations can still develop breast cancer through other causes, like all women.

Variations are changes in the genetic code that are more common than mutations and associated with common traits and diseases. DNA variants increase the likelihood that you may have a trait or develop a disease but do not determine or cause it. Association means that in several large study populations, a DNA variant was more frequent among people with the trait than those without, often only slightly more frequent.

These variants don’t determine a trait, but increase its likelihood by interacting with other DNA variants and nongenetic influences such as upbringing, lifestyle and environment. To design such traits in embryos would require multiple DNA changes in multiple genes and orchestrating or controlling relevant environment and lifestyle influences too.

Let’s compare it to driving a car. DNA mutations are like the flat tires and the failing brakes: technical problems that make driving problematic, no matter where you drive. DNA variations are like the color and the type of car, or other features of the car that may affect the driving experience and even might create problems over time. For example, a convertible is a delight when driving on Hollywood’s Sunset Boulevard on a breezy summer evening, but cruel when crossing a high mountain pass in midwinter. Whether features of the car are an asset or a liability depends on the context and that context might change — they are never ideal all the time.

Another hurdle

Most DNA mutations do nothing else other than cause the disease, but DNA variations may play a role in many diseases and traits. Take variations in the MC1R “red hair” gene, which not only increases the chance that your child will have red hair, but also increases their risk of skin cancer. Or variations in the OCA2 and HERC2 “eye color” genes that are also associated with the risk of various cancers, Parkinson’s and Alzheimer’s disease. To be sure, these are statistical associations, reported in the scientific literature, some may be confirmed; others may not. But the message is clear: Editing DNA variations for “desirable” traits may have adverse consequences, including many that scientists don’t know about yet.

We can see this in the analysis of He Jiankui’s gene-edited babies . By trying to make the babies resistant to HIV, He might have greatly increased susceptibility to infections by West Nile virus or influenza.

To be sure, even though complex traits such as intelligence, athletics and musicality cannot be selected or designed, there will be opportunists who will try to offer these traits, even if totally premature and unsupported by science. Like Stephen Hsu, the co-founder of Genomic Prediction who said about his offer to test embryos for polygenic risk, the risk of a disease based on multiple genes, “I think people are going to demand that. If we don’t do it, some other company will.” And also He said : “There will be someone, somewhere, who is doing this. If it’s not me, it’s someone else.” People need to be protected against this irresponsible and unethical use of DNA testing and editing.

Science brought incredible progress in reproductive technology, but didn’t bring designer babies one step closer. The creation of designer babies is not limited by technology, but by biology: The origins of common traits and diseases are too complex and intertwined to modify the DNA without introducing unwanted effects.

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His baby gene editing shocked ethicists. Now he's in the lab again

John Ruwitch

He Jiankui announced nearly five years ago that he had created the first gene-edited babies. Aowen Cao/NPR hide caption

He Jiankui announced nearly five years ago that he had created the first gene-edited babies.

BEIJING — In a mostly empty coworking office on the outskirts of China's capital, a scientist whose name is etched in history is trying to stage a comeback.

He Jiankui announced nearly five years ago that he had created the first gene-edited babies, twin girls named Lulu and Nana. The news sent shockwaves around the world. There were accusations that the biophysicist had grossly violated medical ethics; some critics compared him to Dr. Frankenstein.

And he paid a price. He was swiftly detained and a Chinese court later sentenced him to three years in prison for "illegal medical practices."

About a year ago he got out, and says he took up golf. Then something unexpected happened.

"There [were] over 2,000 DMD patients, they are writing to me, text me, make phone call to me," he says.

DMD, or Duchenne muscular dystrophy, is a genetic disease that causes muscles to waste away. There is no cure yet. The patients, and their families, had heard about He from his baby project, he says.

"They want me to develop therapy for them," he tells NPR in an interview.

The scientist's move back into the lab comes at a time of lingering questions about his past work — and is raising new concerns among experts about his motivations and those of the Chinese government, which jailed him and tightened regulations on gene editing in the wake of his experiment on embryos.

He's conviction also came with conditions on future work. The government banned He from doing anything related to assisted human reproductive technology, and imposed limits on his work relating to human genes. Many of the details were not made public, however, and he did not respond when NPR emailed him for clarification.

Various Chinese government agencies, including the State Council, the National Health Commission, the Ministry of Science and Technology and Foreign Ministry, did not respond to NPR's requests for comment.

"I did it too quickly"

On a late spring day, He invited NPR to become the first journalists to visit his spartan office to talk about his new project. And quickly it became clear: He was not interested in talking about the past.

He made a series of claims that NPR could not substantiate.

Asked how he felt about what he had done with the gene-edited babies, and whether he had drawn lessons from it, He was vague.

"I did it too quickly. Yeah, I have just been thinking a lot in the past four years. Yeah, I did it too quickly," he says.

Shots - Health News

Creating a sperm or egg from any cell reproduction revolution on the horizon.

Pressed on what that means, he would not say.

What He did was edit the genes in human embryos to try to make them immune to HIV. He was widely condemned because the move sparked fears that he had opened the door further to so-called designer babies — and no one knew whether it was safe or how it might affect the infants' health.

An embryologist who was part of the team working with scientist He Jiankui adjusts a microplate containing embryos at a lab in Shenzhen in southern China's Guandong province on Oct. 9, 2018. Mark Schiefelbein/AP hide caption

An embryologist who was part of the team working with scientist He Jiankui adjusts a microplate containing embryos at a lab in Shenzhen in southern China's Guandong province on Oct. 9, 2018.

So how are those children, now nearly 5 years old?

"Well, what I can tell is they are living a normal, peaceful, nondisturbed life," He says. Again, pressed for details — like where they are now and whether the gene editing had any negative effects — he declined to comment. He says it's important for the world to know about these issues eventually, but not now.

2 Chinese Babies With Edited Genes May Face Higher Risk Of Premature Death

He also would not say a word about his prison experience.

"I don't want to talk about that anymore. ... Just let it go," he says. "I think no one can rewrite history and go back there and do [it] a better way or something. No. I just want to let it go so I can move on to my new project to cure patients."

He's using CRISPR in his new lab

He says he has set up a new lab — the Jiankui He Lab — where he's using the gene-editing tool CRISPR to come up with a cure for DMD. CRISPR is the technology he used to edit genes in embryos, but he says his current work is not focused on tweaking genes at that level and the edits will not be passed from one generation to the next.

"The idea is we have a single shot that contains materials that will do the gene editing. We inject it in the blood so it will spread to the whole body and reach the muscle, the muscle cells, get into the muscle cells, and precisely pick up the mutant gene and make it functional, correct it. And the patient is going to recover from the disease," he says.

He says he's got some seed money, including from two American donors whom he will not name. He has five staff working with him, and other "collaborators" outside Beijing. He did not invite NPR to visit the lab, which is in Beijing.

"Currently we are at a stage [where] we design the experimental protocol and we are testing some of the formula. In a few months we are going to do the animal studies, using mice," He says.

After mice — with approval from an ethical review board — the testing moves on to dogs, then monkeys. And he says he hopes clinical trials on humans can start in 2025.

That makes some people nervous.

Experts say the science was bad

"He very much wants to rehabilitate his reputation," says Kiran Musunuru, a professor of medicine at the University of Pennsylvania who is an expert in gene editing and has followed He's case closely.

The professor says in editing babies' genes, not only did He cross ethical lines, the science itself was bad.

And now the odds are heavily against He coming close to a cure in such a short time on the cheap, Musunuru adds, given that several major drug companies have been working on it for years.

"There's a reason why it's so expensive to develop drugs and why it takes so long. Because you have to have a very, very, very high bar in terms of rigor. You got to make sure that this is safe, otherwise, you know, your patients are going to die when you give them a treatment that's not well vetted," he says.

A group of Chinese scientists and legal experts have called on the authorities to ban He from experiments involving people. The group also said in a statement the authorities should investigate He for alleged "re-violation of scientific integrity, ethical norms, laws and regulations."

Scientists Call For Global Moratorium On Creating Gene-Edited Babies

But the critics don't seem to faze him.

He studied in the United States

"I'm a scientist. I was trained in college in the United States to be scientist to solve science problem, to do something help [to] people. That's something in my blood. It's not easy to change," he says.

He got his Ph.D. in physics at Rice University in 2010 and did postdoctoral research in a Stanford biophysics lab.

But observers wonder: Why would the Chinese government allow a convicted criminal to get back into the gene-editing game?

Ben Hurlbut, an expert in bioethics at Arizona State University, considers it could have to do with global competition.

"What's at stake is a kind of race for supremacy in biotechnology, and you know that kind of has a nationalist dimension to it," he says.

He Jiankui is not some rogue scientist who went off the rails, Hurlbut says. He had support and others in China knew what he was doing. The baby gene-editing project may not have played well with the international community, but what He did was an undeniable first. China was first.

But what He is doing is "a mixture of reckless and absurd," says Hurlbut, who is struck that He would be allowed to begin the new research. "The nature of the sort of authorization and even support that he's getting is interesting."

The Chinese scientist says no government people have talked to him about the work and he does not get any financial support from the authorities. "We do have contact with them [to] make sure that every step we do is follow[ing] the Chinese guidelines and laws," he says.

He hopes for better luck next time

He is now focused on the path ahead. And he says trust in him should not be based solely on previous experience.

"It's based on what I'm doing at this moment. And show the data we have. Show the approval we have. Show the ethic guidelines we have. Everything. That will build the trust," he says.

If you do things right, you don't need to worry about critics, he says. "And if it's safe and effective and [you] get all the necessary governmental or institutional approval then we should be OK to move on."

His current work, he says, is based on a clear medical need. He maintains it follows international guidelines and is being conducted with the necessary approvals, informed consent and transparency — claims which NPR could not verify.

Gene therapy for muscular dystrophy stirs hopes and controversy

He says he's already talking with sufferers of other genetic diseases, such as familial hypercholesterolemia and mucopolysaccharidoses, who want his help.

Musunuru, the University of Pennsylvania professor, is highly skeptical.

"You know, he's not a physician. He has no medical training whatsoever. He has no training in clinical trials. He took it upon himself to run what he viewed as a clinical trial," Musunuru says. "And, you know, to fast forward several years and what he's doing now, I can see it playing out all over again."

In the coworking office, on He's desk is a copper statuette of Guan Gong — a Taoist god who represents loyalty to the king, and is said to keep bad fortune at bay. He recently traveled to the Wudang Mountains, in central China, where he consulted a Taoist priest about his fortune.

"He told me after extremely bad luck comes good luck," He says.

NPR producer Aowen Cao contributed reporting in Beijing.

• gene therapy
• muscular dystrophy
• gene editing
• gene-editing

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• Case Study in Three Parent Embryos
• Case Study in Prenatal Diagnosis and Sex Selection
• Case Study in Lethal Diseases and Autonomy
• Case Study in Personal Genome Services

Case Study in Fertility Clinics and Designer Babies

• When a Case Study is Not Hypothetical
• Case Study in the Right NOT to Know
• Case Study in Genetic Testing for Sports Ability
• Case Study in Genetic Discrimination
• Case Study in DNA, Privacy and Human Cloning
• Case Study in Recombinant DNA Technology and Biosafety
• Case Study in Forensic Paternity Testing
• Case Study in Genetics and Mental Illness
• Case Study in GM Food Animals
• Case Study in Tissue Ownership
• Case Study in Savior Siblings
• Case Study in DNA Fingerprinting
• Case Study in Incidental Findings
• About Genetics Generation
• Genetics Generation
• Women in Science

By Andrea Tunnard and Laura Rivard

Introduction

In late September, the consumer genetics company 23andMe announced that it had been awarded a patent for statistical analysis methods that can be used to make predictions about an unborn child's traits based on genes in the parents. This is presented on their website as the " Family Traits Inheritance Calculator ", and it has been available to couples since 2009 (both parents must be 23andMe customers) . It offers predictions for inherited traits such as eye color, curly hair, and lactose intolerance. 23andMe claims that the Family Traits Inheritance Calculator offers an "engaging way for you and your partner to see what types of traits your child might inherit." The calculator is presented as a tool, a more scientific way of predicting a baby's appearance.

23andMe filed for the patent in 2008. The document, made public as part of the granting process, contained a surprising revelation. The focus of the patent, as it was written five years ago, is for the use of their statistical tests in choosing the "best" gamete donor during infertility treatment. The patent outlines a process for the application of 23andMe's technology in fertility clinics . According to the patent, prospective parents may select a "phenotype of interest" for their child. Then, a particular donor can be selected from a pool of donors based on the likelihood that the resulting child will express the "phenotype of interest" when the donor's gametes are matched with one of the parent's. Fertility clinics already have technology to screen embryos for harmful diseases. However, 23andMe's patent takes this approach in a new direction by encompassing non-disease related traits. The list of traits from which prospective parents may select (as detailed in the patent) include eye color, allergies, muscle composition relating to athletic performance, and even life span. A diagram from the patent presents the trait options in a mock-up of a pull-down menu. Below are actual figures from the 23andMe patent "...illustrating an embodiment of the user interface for making user specification and displaying the results".

Although the newly awarded patent protects 23andMe's right to use their technology to screen prospective parents before in vitro fertilization, the company says it has no plans to do so, and that they were merely protecting the possibility of venturing into the in vitro market when they filed the patent in 2008. They claim their trajectory as a company has changed since filing the patent, as outlined in a press release:

"At the time [23andMe] filed the patent, there was consideration that the technology could have potential applications for fertility clinics so language specific to the fertility treatment process was included in the patent. But much has evolved in that time, including 23andMe's strategic focus. The company never pursued the concepts discussed in the patent beyond our Family Traits Inheritance Calculator, nor do we have any plans to do so."

Still, now that the technology is theirs exclusively, the temptation to pioneer this application of genetics in fertility clinics, and the financial incentive included, will be enticing. Are "designer babies" close to becoming a reality?

Please take our poll and leave a comment. This technology is perfectly legal and is unlikely to become illegal. Therefore a discussion of the ethics involved is critical.

References:

Callaway, Ellen. " Personal Genetics Firm Denies Pursuit of ‘Designer Babies .'" Scientific American . October 2, 2013.

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This is not a comment but just a "thank you card" to Dr. Rivard for the meaningful and insightful forum "Genetics Generation". I am the administrator of the " BJU Department of Biology " facebook page, and I posted the commentary on fertility clinics&designer babies on our page. The article has been read and appreciated by many in our University, and I wish other faculty will promote more discussions on the topic

I think an important consideration in this kind of disucssion is also the quality of the information/prediction available. Many traits are quantitative, so an exact prediction of the phenotype can't be made (and that's ignoring the role of other influences during development). Aside from the responsibility & difficulty of informing couples about this, what happens if/when a couple "designs" a baby with trait X (eg, above average height) but the child turns out differently? Will the child suffer because of the parents' disappointiment? Do the parents have a legitimate claim the company that advised them or the fertility clinic? Or if the desired phenotype is realised, what effects do the resultant expectations have on the child (eg, become an athlete, a researcher, etc)? I don't have the answers, but I'm glad that I've got lots of questions...

Nature works on very sophisticated and, according to what I believe, instilled equilibria. The "laws" that regulate these equilibria are hard to comprehend, and we have no idea of how a trait-driven genetic selection may impact the dynamics within the human community.

I find the concept of "designer" babies very disturbing. On the other hand, is it better to allow a child's characteristics to be determined "naturally," i.e. arbitrarily? Also, as a lawyer, I can't help but consider whether or not my---or anyone's--misgivings should constitute a basis for a proscription against other's (legal) right to make such choices.

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Benefits of Designer Babies: a Persuasive Argument

How it works

• 1 Introduction
• 2 Ethical Considerations
• 3 Potential Benefits
• 4 Regulatory and Ethical Safeguards
• 5 Conclusion

Introduction

Alright, so genetic engineering and biotech have brought about some pretty big changes in medicine and biology. One of the hot topics here is “designer babies”—kids whose genetic traits are picked or changed before they’re even born. This idea has sparked a lot of debates on ethics, society, and science. Some folks think messing with genes raises serious moral issues and could be risky. Others believe it could wipe out hereditary diseases and boost our abilities. In this essay, I’ll look at the ethical side and the good stuff about designer babies, arguing that, if done right, genetic engineering could make huge strides for humanity.

Ethical Considerations

The ethics around designer babies are pretty tricky and complicated. A big worry is that it could lead to a new kind of eugenics, where some traits are seen as better, making social gaps even wider. People are concerned that parents choosing traits like smarts, looks, or athletic skills could split society into the “enhanced” and the “natural.” Plus, the idea of “playing God” by changing human genes brings up deep moral questions about how much we should mess with nature.

But we should separate genetic changes that treat diseases from those that just enhance traits. Treatments aim to stop or fix genetic issues, making life better and cutting medical costs for chronic diseases. Like, if we could get rid of genes that cause cystic fibrosis or Huntington’s, it could save a lot of folks from tough illnesses. In this sense, genetic engineering is kinda like other accepted medical treatments, like vaccines and organ transplants.

Potential Benefits

The good stuff about designer babies isn’t just about stopping hereditary diseases. Advances in genetic engineering could boost human abilities, leading to better brains, health, and overall happiness. Imagine being more resistant to common bugs like the flu or having sharper cognitive skills—this could really impact public health and productivity. And those with genetic enhancements might push boundaries in science, art, and sports, driving human progress in ways we can’t even imagine yet.

What’s more, if we handle genetic engineering responsibly, it could mean more equality by giving everyone a shot at a healthier, happier life. Making sure genetic modifications are available to all and well-regulated can help prevent widening the gap between the haves and have-nots. Policies that ensure fair access and ethical checks can help balance the benefits and risks, aiming for a world where genetic enhancements benefit society as a whole, not just a select few.

Regulatory and Ethical Safeguards

To tackle the ethical worries and possible risks of designer babies, we need strong rules and ethical guidelines. Working together internationally and agreeing on the right ways to use genetic engineering is key to avoiding misuse and ensuring responsible application of gene changes. Regulatory bodies should keep an eye on how these technologies develop and are used, making sure they stick to ethical standards and focus on people’s well-being.

Also, getting the public involved and educated is super important for having informed talks about genetic engineering. By including various folks—scientists, ethicists, policymakers, and regular people—in the decisions, we can get a full picture of the pros and cons of designer babies. Clear communication and ethical discussions can help build trust and ensure these technologies are used in ways that fit our societal values and goals.

The talk about designer babies covers a lot of ethical, social, and scientific ground. While we can’t ignore the risks and moral questions, using genetic engineering responsibly could bring big benefits for people. By getting rid of hereditary diseases, boosting human abilities, and promoting equality, genetic changes could lead to a healthier, richer society. But to get there, we need strong rules, ethical checks, and informed public input. As we deal with the intricacies of genetic engineering, it’s crucial to balance innovation with responsibility, making sure our progress matches our shared values and dreams.

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