Biohacking oversight when the stakes are high (2023)

I. Introduction

There is a gap in the scientific field of research ethics where the behavior of biohackers (often in their garages) is dismissed as unscientific[i]. Bio-hacks, such as former NASA scientist Josiah Zayner's attempts to increase muscle mass by disrupting the myostatin gene using the Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Cas9 system, using himself as the test subject, have passed none of the usual institutionalized ethics monitors[ii]. Some argue that biohacking, which involves the unauthorized or unethical exploitation or experimental modification of genetic material, is illegal and therefore has nothing to do with research ethics or the IRB.[iii] In 2009, the US Federal Bureau of Investigation (FBI) join forces with unusual allies[iv]: biohackers. The FBI did this by hosting them at the International Genetic Engineering Machines (iGEM) contest to educate and connect the US government and biohack community[v].

Biohackers should be subject to research ethics committees, known as the "ethics police,"[vi]regardless of FBI involvement in prosecution if they break the law. One could even argue that the bioethical principles often discussed in research ethics might be compatible with the goals of biohackers. Both bioethicists and biohackers argue that equal access and equity should be sought, but the means by which this can be achieved vary widely. Bioethicist and journalist Alex Pearlman is leading a project to help biohackers set their own standards. The article argues that the ethical behavior of biohackers falls within the broad realm of research ethics, with an emphasis on practical implications and recommendations.

Biohacking refers to any form of tweaking or enhancing the body or mind and is part of synthetic biology and the DIY (do-it-yourself) community.[viii]The human enhancement market is estimated to reach 2.3 billion by 2025 US dollars are growing.[ix ] ]Given these numbers, biohacking is not an irritating fad, but a clear trend. Social phenomena do not exist in isolation; They are influenced by cultural and political values.[x]Their behavior implies a general disregard for authority and a desperate attempt to democratize science[xi]and its clinical applications and make them accessible to all.The behavior of biohackers needs to be considered are in scientific research. Biohacking is part of general scientific research and therefore falls within the ethos of science.[xii]

While biohackers typically operate from the comfort of their own homes or online, many of them first came together for iGEM in 2003 at the Massachusetts Institute for Technology. In 2011, 165 teams took part in the competition, with more joining in 2012.[xiv]Projects ranged from "...rainbow-pigmented bacteria and banana-scented bacteria to an arsenic biosensor."[xv]Today there are Communities like Biobricks offer online education and training, and Genspace (NYC) offers a community biolab.[ XVI]

II. Background: paradigm shift

We owe scientific inquiry to Greek philosophers like Socrates, Plato and Aristotle, who used reason, not myth and story, to explain the world around them. Today's publishing industry is worth billions and is fueled by the exponential accumulation of data.[xvii]Research includes all basic, applied, and proven research.[xviii]Research records such as progress reports, journal articles, and laboratory records constitute the facts of scientific research.

As science developed, there was a shift from open science (think of the Wright brothers who made the first successful airplane) to the centralized institutionalization of science. Moreover, the foundations upon which ethical research is built are "...a set of values ​​and norms which are considered binding on the scientific man."[xix] The norms guiding research practice are communism, universalism, Selflessness and organized skepticism.[xx]Stehr distinguishes between the social and cognitive norms of science and identifies a gap between scientific ideas and scientific practice.[xxi]These changes have inevitably been accompanied by a strong drive towards monetization. Therefore, in both biohacking and mainstream science, it would be prudent to keep in mind the possibility of reasonable compromise in the objectivity of the facts. It is an evolving process in which scientific, societal and economic factors drive research and its clinical application.tj.,which ultimately ends up on the market.[xxii]

Research oversight and clinical application of CRISPR-Cas9, a bacterial immune defense system[xxiii] that can easily and inexpensively edit any genome, has been patchy and controversial. In 2015, Jennifer Doudna, one of the discovery's lead scientists, called for a temporary moratorium on the use of CRISPR for clinical editing of human genes pending further research. [xxiv] It should be clear that the clinical use of CRISPR in germ cells, which are heritable changes in human sperm or oocytes, should not take place anywhere in the world. However, later events indicate that this was not enough. In 2018, He Jiankui took advantage of this gray area by editing hereditary changes in human embryos, and two girls were born. He Jiankui claimed that CRISPR altered the genomes of these children, targeting the CCR5 gene to make them HIV-resistant, even though he knew their father was HIV-positive. However, this was a violation and a breach of ethics as there are much safer and more effective ways to prevent HIV infection during the in vitro fertilization process. It is unacceptable to transplant genetically engineered cells into the human uterus. [xxv] In response, an established group of 18 scientists from seven countries called for a worldwide moratorium on the creation of genetically modified children. [xxvi] This example of a scientist's use of arcane surveillance to use CRISPR technology to alter humanity's gene pool is a reminder that much is at stake.

Additionally, in 2019, the National Academy of Medicine and the National Academy of Sciences, as well as the UK Royal Society and others, established the International Commission on the Clinical Exploitation of Human Germline Genome Editing to establish new, stricter, and clearer recommendations that may be included in The future applies[xxvii] The World Health Organization (WHO) also established the WHO Expert Advisory Board on the Development of Global Standards for the Management and Monitoring of Human Genome Editing in 2019 to produce a comprehensive report that avoids ambiguity[xxviii]. This report is expected to be published in summer 2020.

Biohackers' unconventional research methods are mainly due to the constraints imposed on large institutions. The tedious process of turning to ethical protectors protected by academic institutions[xxix] also triggers biohacking. These rules and regulations can discourage research, slow discoveries, and make it difficult to provide much-needed solutions for people living with disease. Too many rules are an obstacle to open science. However, without ethical oversight, biohacking would continue unchecked, potentially compromising security. The difference between research by professional scientists and biohackers is that biohackers can do things that are forbidden by mainstream science. [xxx] Experiments without supervision can result in risks that outweigh the benefits. Biohacking without respect for ethics is not in line with WHO guidelines on scientific integrity.[xxxi]Some argue that widespread adoption of CRISPR-Cas9 technology could follow in the footsteps of the personal computer.[xxxii]People were skeptical about personal computers across from home, and today everyone has a smartphone in their hands – generally unregulated and used by the public as they see fit.

III. The scope of research ethics

The field of research ethics covers an infinite and diverse field of research.[xxxiii] Legally binding documents such as the Nuremberg Code[xxxiv], the Declaration of Helsinki[xxxv] and the Belmont Report[xxxvi]help guide the inevitable human inquiry through the Request for informed consent and IRB approval/REC. The Helsinki Declaration of the World Medical Association[xxxvii] states: “The primary purpose of medical research is to generate new knowledge, but this must never take precedence over the rights and interests of the individual research subject.”[xxxviii] Medical research involves human beings Subjects "shall conform to generally accepted scientific principles and be based on a thorough knowledge of the scientific literature, other relevant sources of information, and appropriate laboratories and, where appropriate, animal testing."[xxxix] "The design and operation." Any scientific research involving human subjects must also be clear in the study protocol be described and justified."[xl]

Biohackers typically do not have officially approved protocols, and this lack of clarity is exacerbated when biohackers exercise their right to autonomy and informed consent by “enrolling” as research participants in their own experiments, bypassing the role of the IRB . The primary responsibilities of the IRB are to ensure the scientific relevance, quality and integrity of research, to consider the interests of all potential stakeholders and to conduct an appropriate benefit-risk assessment.[xli]Follow these standards for the Research Ethics Review System[xlii]. a structured approach. This means that all human research is “presumably subject to IRB oversight” and also forms part of larger research participant protection programs that ensure effective training and efficient operations.

According to the Structured Approach of the WHO[xliii] biohacking is part of the broad realm of research ethics and falls within the ethos of the norms of the scientist.[xliv] Biohackers promote the norm of communalism because scientists draw on existing scientific evidence and base their search for new discoveries based on meaningful data. [xlv] Even unconventional research cannot be done without building on previous discoveries. Biohackers are part of the broader scientific community.

An alternative proposal is that biohackers are self-governing. Some advocate the institutionalization of biohackers, which could argue for a norm of universalism, with networks like diybio.org promoting collective self-government by biohackers. Alex Pearlman, a bioethicist and journalist, wants to help develop a set of norms specific to biohackers. There is an urgent need to create a framework for the systematic assessment of the risks and hazards of biotechnology.[xlvi]

One could argue that biohackers do not violate bioethical principles because they are conscious and autonomous. They show respect for their autonomous decisions by choosing themselves as research participants,tj.,Promote the principle of distributive justice and charity. However, when they do germline editing, there are risks and consequences for humanity that are already heavily regulated by bioethical standards. Biohackers should not be exempt from clearly defined rules just because they claim to operate under different rules. In structured scientific communities, researchers cannot claim that autonomy allows them to violate the Helsinki standards.

The field of research ethics should adapt to the paradigm shift where biohackers are making important scientific discoveries. Attempting to involve the FBI rather than putting them in charge would lead to a collaboration to develop an ethical framework and provide clear guidance to biohackers. Some may argue that the FBI's oversight is sufficient as a police force. However, the FBI decides to do the actual act of biohacking by declassifying iGEM. Including biohacking in the field of research ethics would address the ethical behavior of biohackers in research ethics and engage biohackers in the process of creating a systemic ethical framework.

IV. Practical considerations

Opposing critics might argue that involving biohackers in the research poses a number of complications. Some argue that the IRBs are overloaded and that there is no adequate oversight of biohackers. However, there is too much at stake to not take on the challenge of implementing a surveillance system.

Some also claim that biohackers are not currently doing any important research. Messy experiments in the kitchen don't equal accurate measurement of scientific results. Even if sufficient empirical data were collected, their research design would be likely to have n=1 hypotheses, which is irrelevant (p<0.05). However, Chinese twins and other experiments show both an active field and the promise of new preventive and curative measures. As biohackers make increasingly meaningful discoveries, structured ethical oversight is needed.

V. Conclusion

Research ethics have not adequately solved the ethical conundrum of biohackers. Biohackers point to a paradigm shift from centralized power back to decentralization with a strong emphasis on the democratization of science. While biohackers can lead to more accessible research and advance science, the new paradigm requires oversight in creating ethical frameworks that they must adhere to. Biohackers themselves should be invited to engage in the traditional scientific arena, to help formulate ethical guidelines and to present their point of view and scientific goals.

More thought should be given to how research can be made more accessible to all. Bioethicists and IRB specialists can explore how disease treatments can be brought to market in a more time-efficient, yet safer manner. A balanced approach would commit biohackers to ethical standards while addressing their concerns about scientific freedom and market access to new discoveries. Biohackers should be allowed to continue hacking into garages and basements in the hope of making a lucrative and scientifically sound discovery, albeit one that is ethical.

[i] Gaymon Bennet et al., "From Synthetic Biology to Biohacking: Are We Prepared?",natural biotechnology27, No. 12 (December 2009): 1109–11.

[ii] George Blazeski, "Need for Government Oversight of Self-Biohacking, Synthetic Biology in the Wild West",Scholarship for law students, 2014, https://scholarship.shu.edu/student_scholarship/411.

[iii] Howard Wolinsky, "The FBI and the Biohackers: An Extraordinary Report",EMBO reports17, No. 6 (June 2016): 793–96, https://doi.org/10.15252/embr.201642483.

[iv] Howard Wolinsky, "The FBI and the Biohackers: An Unusual Relationship",EMBO reports17, No. 6 (June 2016): 793–96, https://doi.org/10.15252/embr.201642483.

[v] Blazeski, “The Need for Government Oversight of Do-it-Yourself Biohacking, the Wild West of Synthetic Biology.”

[vi]Robert L. Klitzman,Ethical Police, Kindle (Oxford: Oxford University Press, 2015).

[vii] Delia Paunescu, "Can You Be an Ethical Biohacker?"Wok15. October 2019, https://www.vox.com/recode/2019/10/15/20915402/biohacking-josiah-zayner-crispr-ethics-gene-editing-reset-podcast.

[viii] Blazeski, “The Need for Government Oversight of Do-it-Yourself Biohacking, the Wild West of Synthetic Biology”; Anna Wexler, "The Social Context of Do-it-Yourself Brain Stimulation: Neurohackers, Biohackers and Lifehackers",Frontiers of human neuroscience11 (10 House 2017): 224, https://doi.org/10.3389/fnhum.2017.00224.

[ix] Stefan Nicola, "Biohackers implant everything from magnets to sex toys",Bloomberg Business Week, 19. October 2018, https://www.bloomberg.com/news/articles/2018-10-19/biohackers-are-implanting-everything-from-magnets-to-sex-toys.

[x] Wexler, "The Social Context of Do-it-Yourself Brain Stimulation."

[xi] Wexler.

[xii] Robert K. Merton,Sociology of science: theoretical and empirical research, 4. Dr. (Chicago: Univ. of Chicago Pr, 1974).

[xiii] Blazeski, "The Need for Government Oversight of Do-it-Yourself Biohacking, the Wild West of Synthetic Biology."

[xiv] Blazeski, "The Need for Government Oversight of Do-it-Yourself Biohacking, the Wild West of Synthetic Biology."

[xv] Blazeski.

[XVI] Blazeński.

[xvii] Jason Schmitt, "I Can't Disturb: Elsevier and the $25.2 Billion Academic Publishing Business,"MediocreDecember 22, 2015, https://medium.com/@jasonschmitt/can-t-disrupt-this-elsevier-and-the-25-2-billion-dollar-a-year-academic-publishing-business-aa3b9618d40a.

[xviii] Kenneth Pimple, "The Six Domains of Research Ethics: A Heuristic Framework for Responsible Research",ethics of science and technology8, no. 2 (2002), http://nordmansustainability.com/wp-content/uploads/2013/01/Six_domains_of_research_ethics.pdf.

[xix] Nico Stehr, „The Ethos of Science Revisited Social and Cognitive Norms“,sociological investigation48 (1978): 3–4.

[xx]Alessandro Delfanti, Hacking Genomes. Ethics of open and rebellious biology",International Review of Information Ethics15, nie. 52–57 (nd), https://s3.amazonaws.com/academia.edu.documents/6747790/015-delfanti.pdf?response-content-disposition=inline%3B%20filename%3DHacking_genomes._The_ethics_of_open_and.pdf&X-Amz -Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=AKIAIWOWYYGZ2Y53UL3A%2F20191119%2Fus-east-1%2Fs3%2Faws4_request&X-Amz-Date=20191119T200519Z&X-Amz-Expires=3600&X- Amz- SignedHeaders=host&X-Amz -Signature=f4698da128020d859009dba7b7e3355912cb0b00b281107dbf6150dfb5548596 .

[xxi] Stehr, „The Ethos of Science Revisited Social and Cognitive Norms“.

[xxii] Delfanti, “Hacking Genomes. The ethics of open and rebellious biology”.

[xxiii] Broad Institute, „CRISPR Timeline“, nd, https://www.broadinstitute.org/what-broad/areas-focus/project-spotlight/crispr-timeline.

[xxiv] Lucie Wade, „Ideologie intelektu A Critical Examination of the Hype Surrounding Cognitive Enhancement“ (Kanada, McGill University, 2011).

[xxv] Eric S. Lander et al., „Adopt a Moratorium on Hereditary Genome Editing“,Nature567, No. 7747 (March 2019): 165-68, https://doi.org/10.1038/d41586-019-00726-5.

[xxvi] Lander i in.

[xxvii] Towarzystwo Królewskie, „International Commission on Clinical Use of Human Germline Genome Editing“, 2018, https://royalsociety.org/topics-policy/projects/genetic-technologies/international-commission/.

[xxviii] WHO, “WHO Expert Panel Paves Way for Strong International Governance on Human Genome Editing”, 19 March 2019, https://www.who.int/news-room/detail/19-03-2019-who – Panels of experts pave the way to strong, international governance for human genome editing.

[xxix] Sarah Zhang, "Biohacker regrets publicly injecting himself with CRISPR",AtlanticFebruary 20, 2018, https://www.theatlantic.com/science/archive/2018/02/biohacking-stunts-crispr/553511/.

[xxx] Zhang.

[xxxi]WHO, „Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participant“, 2011, https://www.up.ac.za/media/shared/190/ZP_Files/who-research-ethics -committees_1.zp43599.pdf.

[xxxii]R. U. Sirius und Jay Cornell,Transcendence: The Disinformation Encyclopedia of Transhumanism and the Singularity(San Francisco, CA: Desinformation Books, Red Wheel/Weiser, LLC, 2015).

[xxxiii] Pimple, "Six Domains of Research Ethics, A Heuristic Framework for Responsible Research Behavior."

[xxxiv] The Nuremberg Codex, undated.

[xxxv] Zhang: "Biohacker regrets publicly injecting himself with CRISPR."

[xxxvi] World Medical Association, "WMA Helsinki Declaration - Ethical Principles of Medical Research Involving Humans", 1964.

[xxxvii] National Commission on the Protection of Human Biomedical and Behavioral Research Subjects, "Ethical Principles and Guidelines for the Protection of Human Research Subjects, Commonly Known as the "Belmont Report", 1979.

[xxxviii] World Medical Association, “WMA Helsinki Declaration – Ethical Principles of Medical Research Involving Humans.”

[xxxix] World Medical Association.

[xl] World Medical Association.

[xli] WHO, “Standards and Operational Guidelines for Review of Ethics in Research Related to Human Health”.

[xlii] WER.

[xliii] WER.

[xliv] Merton,sociology of science.

[xlv] Merton.

[xlvi] Bennet et al., "From Synthetic Biology to Biohacking: Are We Prepared?"

Castelyn, C. (2020). Biohacking Oversight When The Stakes Are Big: Ethics Police or FBI?Voices in Bioethics,6. https://doi.org/10.7916/vib.v6i.5898