ethics

Nature Magazine weighs in on issues surrounding industry/academic collaboration in the life sciences

Katy Armstrong — Wed, 18 Jun 2008 16:30:53 -0700

Description

Robin Mejia, writing for Nature Magazine, reports on some of the practical and ethical issues surrounding accepting corporate funds to conduct academic research in the life sciences. (1)

"Maintaining scientific integrity in a world where academic research and profit-seeking industry overlap is a challenge for many nations and individual scientists" (2). Restrictive contracts surrounding the publication of study results, and ability to cut funds mid-study the potential to draw the results of industry-backed studies into question. Indeed, Peter Gøtzsche, director of the Nordic Cochrane Centre in Copenhagen, Denmark, found that in Denmark most corporations retained the rights to the data uncovered by the studies they sponsored, whereas David Ludwig, director of the obesity program at Children's Hospital Boston in Massachusetts, has found that corporate-backed studies are more likely to produce results that benefit the corporation than independently funded studies.

These issues are particularly pertinent where and when government funding for research is difficult to obtain.

Although different scientists have diverse perspectives on whether it is ever appropriate to accept corporate funding, Mejia concludes, "Industry funding can provide valuable research support for academics, but such arrangements must be handled with care." (1)

Ethics in Science

Source

1) Robin Mejia, 2008. Taking The Industry Road. Nature 453, 1138-1139
2) Gene Russo, 2008. Prospects. Nature 453, 1137

Investigation of Harvard psychiatrists highlights inadequate regulation of commercially funded research in academic institutions

Katy Armstrong — Tue, 17 Jun 2008 19:10:13 -0700

Description

Joseph Biederman and Timothy E. Wilens, both Harvard professors of psychiatry, are under investigation for failing to report millions of dollars in "consultant fees" received from pharmaceutical companies over the past decade. Both professors received government research grants requiring disclosure of any additional research monies received. In addition, Harvard limits the amount of corporate funding for conducting clinical trials to $10K, so the researchers appear to be in violation of multiple regulations designed to limit potential conflicts of interest between publicly funded basic research and corporation-backed translational research.

In addition to emphasizing the need to improve the execution of existing regulations, and possibly expand them further such as through the creation of a national research funding registry, news of the investigation also casts a cloud of doubt on the scientist's research. Dr. Biederman's research, for example, promotes the treatment of antipsychotic drugs in young children to treat bi-polar disorder. Both the disease, and its treatment, are controversial topics fraught with questions about the subject nature of diagnosis, concerns over the long-term effects of medication as well as possible developmental consequences.

Ethics in Science

Source

http://www.nytimes.com/2008/06/08/us/08conflict.html?ref=health

Ecohacking

Janie Busby Grant — Wed, 04 Jun 2008 15:52:12 -0700

Description

It sounds like something from B-movie lore. Scientists working to avert global catastrophe invent a terrible technical instrument that could affect the fundamental way that the planet operates. The question is not whether they should use it, but whether they have a choice. In both academic and privately funded laboratories, such techniques are being considered, mostly in response to global warming. Geoengineering, or "ecohacking" - using science to change the environment on a vast scale - could become a reality faster than you think.

The possibility of deliberately, artificially altering the envioronment to address specific threats or reach particular aims is familiar to readers of science fiction (see the 'Red Mars', 'Green Mars', 'Blue Mars' series for perhaps the most famous example), but is being raised ever more often in serious scientific circles. Examples include the proposal to release particles of sulpher into the atmosphere to cool the planet, placing a mesh of tiny refractors into space to deflect light rays away from the planet, and inserting huge tubes into the ocean which will pump cooler water to the surface, bringing nutrients and encouraging phytoplankton to grow.

Needless to say, the ethical implications of these types of actions are momentus, not only in and of themselves (can we? should we?), but because unintented consequences of any such 'tinkering' must be considered.

Earth Systems & Environmental Science

Source

http://www.guardian.co.uk/technology/2008/may/29/greentech.geoengineering
http://www.independent.co.uk/environment/scientist-publishes-escape-route-from-global-warming-409981.html

Neuroscientific insights into distributive justice

Alex Soojung-Kim Pang — Wed, 28 May 2008 05:48:46 -0700

Description

Another example of neuroscientists using fMRI to study the way brains work during decision-making, this time when dealing with problems of distributive justice:

Distributive justice concerns how individuals and societies distribute benefits and burdens in a just or moral manner. We combined distribution choices with functional magnetic resonance imaging to investigate the central problem of distributive justice: the trade-off between equity and efficiency. We found that the putamen responds to efficiency, whereas the insula encodes inequity, and the caudate/septal subgenual region encodes a unified measure of efficiency and inequity (utility). Notably, individual differences in inequity aversion correlate with activity in inequity and utility regions. Against utilitarianism, our results support the deontological intuition that a sense of fairness is fundamental to distributive justice but, as suggested by moral sentimentalists, is rooted in emotional processing. More generally, emotional responses related to norm violations may underlie individual differences in equity considerations and adherence to ethical rules.

As the Neuroscientifically Challenged explains,

The investigators found that distinct neural regions are activated in the consideration of equity and efficiency. The putamen, a mid-brain structure that forms part of the dorsal striatum, seemed to be correlated specifically with efficiency. On the other hand, activity in the bilateral insular cortex was correlated with inequity. Regions of the caudate were activated by both. They also found that individual differences in aversion to inequity corresponded with higher neural activity in the insula.

Overall, the participants showed the greatest neural reaction to an inequitable distribution of food, leading the authors of the study to speculate that distributive decisions are made to avoid inequality more so than to engender efficiency. Thus, the results of this experiment seem to support the deontological argument. As the insular cortex is thought to play an important role in emotional processing, the experiment also indicates that our decisions are not devoid of an emotional element (contrary to the beliefs of Kant and Plato).

Thus, the imaging evidence from this study may help to explain why the debate over distributive justice has never been resolved. The concepts of equity and efficiency, and their respective values, are deeply rooted in our brains.

Biomedical Sciences and Biotechnology

Source

Hsu, M., Anen, C., Quartz, S.R. (2008). The Right and the Good: Distributive Justice and Neural Encoding of Equity and Efficiency. Science, 320(5879), 1092-1095. DOI: 10.1126/science.1153651 (or http://www.sciencemag.org/cgi/content/full/320/5879/1092 ).
http://neuroscientificallychallenged.blogspot.com/2008/05/neuroscience-of-distributive-justice.html

Environmental protection body accused of fabricating data

Janie Busby Grant — Thu, 15 May 2008 20:02:28 -0700

Description

Many of the recent cases of data fabrication discussed in the scientific community appear to be due to the desire of the individual scientist to further their own careers. However, another motivating factor for such behaviour can be organisational pressure - not for research output in general - but for specific findings. This is especially the case for data that can have flow-on effects in the near future for organisations, and where a range of other forces (other than scientific advancement) are in play. An alleged case of this type of fraud is described in this week's Nature News.

"A former US Environmental Protection Agency (EPA) scientist is suing the agency's officials and researchers at the University of Georgia in Athens, alleging that they manufactured and published false data to support the use of potentially harmful sewage sludges as fertilizers. The sludges have been linked to health problems in humans and cattle — and even deaths.

The False Claims Act lawsuit brought by microbiologist David Lewis, who says he was forced out of the agency, alleges that EPA officials and University of Georgia researchers fraudulently orchestrated a grant and then fabricated data to ensure that the EPA's 'biosolids' programme would come out smelling pretty. If the charges stick, the scientists and EPA officials could be held personally liable and may be forced to pay back the original grant as well as some US$4.6 million in subsequent grants, plus penalties."

Ethics in Science

Source

http://www.nature.com/news/2008/080514/full/453262a.html

Your Brain on Ethics

Janie Busby Grant — Tue, 13 May 2008 23:06:09 -0700

Description

A new fMRI study examined participants' brain activity while they made decisions with respect to 'the orphanage conundrum':

"Say you have a load of donated food to deliver to an orphanage in Uganda. But due to circumstances beyond your control, you're forced to make a hard choice: give some of the children enough meals to stave off hunger for several days and let the rest go hungry, or evenly distribute a smaller amount of food so that each child feels full for just a few hours."

A series of versions of this problem were presented to the participants, with varying values for the number of meals given/taken away. Findings revealed not only the types of strategies people used in which scenarios, but also linked such moral decision-making with different areas of brain activity, particularly the insula and putamen.

There's been a rapid rise of reseach into emotions, largely through new imagining technology (see earlier post at http://sciencex2.org/en/node/364), as well as widely reported imaging studies tracking/predicting aspects of participants' thoughts. Such research raises the possibility of making judgements or predictions about the moral beliefs or thoughts of another based on brain activity - which engenders a whole host of ethical questions (e.g., potentiality of committing crimes).

Psychology

Source

http://sciencenow.sciencemag.org/cgi/content/full/2008/508/1

Doctors accused of doing illegal stem-cell trials

Janie Busby Grant — Sun, 04 May 2008 23:00:38 -0700

Description

An apparently successful stem-cell treatment for urinary incontinence is now being questioned after it has emerged that clinical trials for the therapy may have been done illegally....
The independent ethics committee that approves and oversees clinical trials at the university and hospital is now concerned that the clinical trial of the procedure's efficacy, carried out by Strasser's team and published in The Lancet last June, may have been illegal. The Ministry of Health is now investigating claims by the ethics committee that it was never contacted, as law requires, about the trial on 63 women who were recruited between 2002 and 2004.

Despite a number of key advances, such as the introduction of registration of controlled trials, use of applicable CONSORT statements, and more rigorous checking at various levels from ethics committees and journal editors, it is clear that some research is still conducted in violation of fairly basic ethical standards.

Ethics in Science

Source

http://www.nature.com/news/2008/080430/full/453006a.html

Ethics of experimental subjects: Humans, animals... plants?

Janie Busby Grant — Tue, 29 Apr 2008 19:59:11 -0700

Description

The Swiss "Gene Technology Law, which came into effect in 2004, stipulates that 'the dignity of creatures' should be considered in any research. The phrase has been widely criticized for its general woolliness, but it indisputably includes plants. All plant biotechnology grant applications must now include a paragraph explaining the extent to which plant dignity is considered... “My first reaction was — what the heck are we doing considering the dignity of plants,” says Schefer. “But this very broad provision exists, and we have to help to prevent a legal mire.”

Ethics in Science

Source

http://www.nature.com/news/2008/080423/full/452919a.html

The dual-use dilemma

Janie Busby Grant — Tue, 29 Apr 2008 18:56:08 -0700

Description

The dual-use dilemma is an ethical conundrum describing the ability of a given item of research to be used for harm as well as for good. That is, in following a particular line of research the intentions of the researcher may be to bring benefit to the scientific community and general public - however, subsequent researchers, individuals or governments may use this research for malevolent ends.

"The dual-use dilemma is obviously a dilemma for researchers, viz. those researchers involved in biological research tha has the potential to be misused by bioterrorists, criminal organisations and governments engaged in biowarfare. But it is also a dilemma for the private and public institutions, including universities, that fund or otherwise enable research to be undertaken... More generally, it is a dilemma for the individual communities for whose benefits, or, indeed, to whose potential deteriment, the research is being conducted, and for the national governments who bear the moral and legal responsiblity of ensuring that the security of their citizens is provided for. Finally, in the context of an increasingly interdependent set of nation-states - the so-called, global community - the dual-use dilemma has become a dilemma for interantional bodies such as the United Nations." (Miller & Selgelid, 2007, p.527)

Ethics in Science

Source

http://www.cappe.edu.au/docs/reports/consultancy/DualUseExecSumm.pdf

http://www.liebertonline.com/doi/pdf/10.1089/bsp.2006.4.276

http://www7.nationalacademies.org/ocga/briefings/Biotechnology_Research_in_an_Age_of_Terrorism.asp

Miller, S. & Selgelid, M. J. (2007). Ethical and philosophical consideration of the dual-use dilemma in the biological sciences. Sci Eng Ethics, 13, 523-580.

Understanding of trial design by participants in RCTs

Janie Busby Grant — Tue, 29 Apr 2008 18:03:05 -0700

Description

Randomised controlled trials are considered the best method of scientifically establishing the efficacy of a given treatment. Such trials involving human participants must meet a range of ethical requirements, including informed consent. This requires that participants are informed of, and understand (!) a range of fairly complicated concepts such as randomisation, double-blinding and clinical (also termed collective) equipoise. There are number of guidelines available to help researchers convey such ideas in an easy-to-read manner. However, research suggests that these steps may not be effective, and that often trial participants suffer from 'therapeutic misconceptions' about the trial they are in - particularly in terms of beliefs that their doctor will always make treatment choices based on what is best for them (which is incompatible with the concept of randomisation). This is perhaps unsurprising given the relatively low level of understanding of science among the general community.

Questions:
- If, upon questioning, participants in a RCT do not understand these concepts, does this render a given trial invalid on ethical grounds?
- What means can researchers use to help participants understand such concepts (given that existing guidelines have already attempted to simplify wording appropriately)?
- What about the possibility of more clearly delineating between a trial and general treatment (given that many trials currently take place by recruiting through the participant's own doctor)?

Ethics in Science

Source

http://jama.ama-assn.org/cgi/content/full/294/17/2262

http://clinicaltrials.gov/ct2/info/understand

Stead, M., Eadie, D., Gordon, D & Angus, K. (2005). "Hello, hello - it's English I speak": A qualitative exploration of patients' understanding of the science of clinical trials, Journal of Medical Ethics, 31, 664-669.

National Science Board. (2002). Science and tecnology: Public attitudes and understanding - public interest in and knowledge of S&T. In: Science and Engineering Indicators - 2002, 7, 1-7.

Legal psychology: Future ethical challenges where the sciences meet the law

Janie Busby Grant — Thu, 22 Nov 2007 13:19:01 -0800

Description

Recent years have seen the incorporation of ever more aspects of psychological science into the legal process. The use of empirical psychological research in a courtroom setting has come to be known as legal psychology, and commonly involves research on topics such as eyewitness memory, decision-making, and group behavior. Forensic psychology, while overlapping with legal psychology, tends to involve a clinical focus and require a more detailed understanding of the legal process. The use of either type of psychology professional within the criminal justice system engenders a number of serious ethical issues, none of which constitute a serious flaw in the relationship between psychology and the law, but all of which need to be scrutinized carefully. The examples of risk evaluations and this issue of informed consent in assessments are discussed below.

A potentially tricky ethical issue is the practice of risk evaluations as performed by psychologists and reported to courts in order to determine an individual's risk for future violence. Critics argue that the use of such assessments in judicial forums is unethical, either because the methods used to gather the data do not meet the legal criteria for admissibility (e.g., scientific verifiability) or that the findings themselves are not appropriately accurate for use in this setting. Authors Tolman and Rotzien argue instead that, "sound ethical practice is about how one practices - the process of an evaluation". They suggest that the competing values of both public safety and potential negative outcomes for an individual need to be taken into account, or decisions could be made subjectively and incorporate emotional and cognitive bias. One major issue Tolman and Rotzien focus on is what they describe as a "tendency to see the role of the expert as a forecaster rather than as an adviser".

Knapp and VandeCreek (2001) discuss some of the ethical dilemmas confronting forensic psychologists, in particular the role of informed consent. Psychologists are ethically bound to inform both the hiring attorney and the client in understandable language of all necessary information.

"The Specialty Guidelines for Forensic Psychologists states that the psychologist should inform the party “of factors that might reasonably affect the decision to contract with the forensic psychologist” (CEGFP, 1991, p. 443). These factors include the fee structure, prior or current personal or professional activities that might produce a conflict of interest, areas of competence and limits to the areas of competence, and the known scientific bases and limitations of the methods and procedures that the psychologist will employ. It also means informing clients about the relevant limitations of confidentiality".

The difficulties involved in informed consent in the legal arena include mandatory evaluations, where by definition the client does not consent to the evaluation process by their own free will. In this context the psychologist still must provide all necessary information, but this issue raises serious questions about their role in mandatory vs traditional clinical psychological evaluations. For instance, do their actions differ in those two situations? Should it? The ability of the client to comprehend the information provided is also often in serious question, particularly when dealing with minors or with individuals with intellectual impairments. The dynamic nature of the legal process also puts additional requirements on the consulting psychologist to keep the client informed of any changes in their role or in the implications of their evaluation. The authors also note that these types of issues are all the more serious given that few psychologists acting as forensic psychologists have been specifically trained in that role.

There are clearly serious ethical issues that must be dealt with when science meet the legal system. If current trends continue psychologists are likely to play a more frequent role in the legal system in the future. In order to support this relationship, changes in education (both at and subsequent to university training) are required in order to appropriately prepare psychologists for work in the legal profession. Without informed debate and critique, scientists (particularly those working in the 'soft' sciences such as psychology) could potentially become a liability to the legal system, rather than an asset. The best-case scenario involves groups of traditional academics working hand-in-hand with those participating in the legal process, supporting them with data-driven findings, which would then be assessed for their applicability by experts in psychology and the law. In summary, it is clear that the field of psychology and other sciences can inform and improve the legal process (see Busey & Loftus, 2006 for a discussion), but it is imperative that any advances be met with considered critique in the context of the legal system.

Knapp, S. & VandeCreek, L. (2001). Ethical issues in personality assessment in forensic psychology. Journal of Personality Assessment, 77, 242-254. Abstract available online at http://www.leaonline.com/doi/abs/10.1207/S15327752JPA7702_07?cookieSet=1&journalCode=jpa.

Tolman, A. O. & Rotzien, A. L. (2007). Conducting risk evaluations for future violence: Ethical practice is possible. Professional Psychology: Research and Practice, 38, 71-71. Abstract available online at http://content.apa.org/journals/pro/38/1/71.

Busey, T. A. & Loftus, G. (2006). Cognitive science and the law. Trends in Cognitive Sciences, 11, 111-117.

Signals

Can and should autism be 'cured'? Implications for society

Janie Busby Grant — Tue, 13 Nov 2007 02:12:25 -0800

Description

Ongoing technological advances bring scientists ever closer to the possibility of curing a wide range of diseases. However, the ethical ramifications of such potential cures become a great deal more complex when applied to mental illnesses or disorders such as autism, bipolar disorder or schizophrenia. Research investigating the aetiology and functioning of these phenomena is progressing rapidly, and although a cure is unlikely in the immediate future, many experts in the field consider the possibility of curing or preventing such disorders realistic in the long term. However, individuals and groups differ widely in the way in which they conceptualize particular mental illnesses, from those that view a particular disorder as an extremely damaging medical condition that needs to be cured, to those that believe the disorder is an intrinsic part of their personality and should be retained at all costs. The highly emotive discussion surrounding a potential cure for autism is used here to explore a wider ethical issue that the sciences may well need to confront in the foreseeable future.

Recently the famed British autism researcher Simon Baron-Cohen argued that he believed autism should be considered as an alternative developmental progression (e.g., similar to left-handedness), rather than as a disorder that should be cured or eliminated. This statement sparked considerable controversy, highlighting the range of views on this topic existing in the community. Groups such as Defeat Autism Now clearly support and promote interventions for people with autism, with the eventual hope of a cure. Take for example a blog post by Harold L. Doherty, a parent of an autistic boy, in which he angrily rejects Baron-Cohen’s comments, arguing that he is “trivialising their life restricting realities with such superficial observations”. In contrast, many high-functioning individuals with autism (or the related condition of Asperger Syndrome) argue that they don’t view their disorder as a disease, and that curing them would essentially destroy part of their personality. A blog on this topic in the Guardian elicited the following comment from an individual with Asperger Syndrome, “… to eradicate part of nature, like black skin or homosexuality, is simply wrong… autism is not an illness… why don’t the curbies [those who promote a cure] ask US before wanting to cure us! We don’t want to change, - it makes us what we are”.

This particular debate is representative of a wider ethical, social and scientific issue surrounding whether mental illnesses require cure. Bipolar disorder is another salient example, particularly given that studies have shown a link between a diagnosis of bipolar disorder and heightened levels of creativity. In a BBC documentary Stephen Fry, a respected British comedian and author with bipolar disorder, notes that if given the choice to eradicate his disorder he would not. The Mercurial Mind Bipolar Blog examining this issue generated many similar responses from those diagnosed with bipolar.

New technologies and scientific discoveries have ethical repercussions, and this is nowhere more obvious than where scientific advances meet the field of mental illness. Significant contributors to the complexity of the debate are problems with diagnosis and categorisation. A simple overview of this issue is presented by Michael J. Carley on the Autism Speaks website, in which he examines the relationship between different ways of categorising autistic spectrum disorders, and how this can muddy the water in terms of the discussion of a potential cure.

In the future this, as yet hypothetical debate, is likely to become a topic of heated public discussion as technological advances progress with respect to treating a range of mental illness. It is likely that, entwined with the intellectual, social and personal issues raised above, there will be debate about the effectiveness and safety of any such 'cure' (as indexed by the reaction to current treatments for mental illness), perhaps driven by misleading or biased information from both sides (again, as seen currently with the promotion of certain prescription drugs). But almost certainly, such scientific advances will lead to protests by individuals or groups attempting to stop the development of these products; researchers should not underestimate the sensitivity of this issue. The entire debate risks heightening the current schism between academics and the general population, with major implications for the way in which scientific research is conducted, and the motivations underlying particular avenues of research. Finally, perhaps an almost sci-fi concern, is the effect on the success of future generations if a potential source of genetic diversity is eradicated, given that we are ignorant of the intellectual and social challenges they will face.

Defeat Autism Now, http://www.defeatautismnow.com/index.html.

Doherty, H. L. (2007, September 12). Why does Professor Baron-Cohen study autism? Facing Autism in New Brunswick, http://autisminnb.blogspot.com/2007/09/why-does-professor-baron-cohen-study.html.

Randerson, J. (2007, September 11). Should we cure autism? The Guardian: Science Blog, http://blogs.guardian.co.uk/science/2007/09/should_we_cure_autism.html.

Stephen Fry: The secret life of the manic depressive, BBC, Info available at http://www.bbc.co.uk/health/tv_and_radio/secretlife_documentary.shtml.

Mom, Interrupted. (2006, December 1). Bipolar disorder: The cost of being cured. Mercurial Mind Bipolar Blog, http://mercurialmindbipolarblog.blogspot.com/2006/12/bipolar-disorder-cost-of-being-cured.html.

Carley, M. J. (n.d.). GRASP, and the word “cure”. Autism Speaks, http://www.autismspeaks.org/whatisit/carley_commentary.php.

Signals

Autism as an acceptable form of diversity

Bipolar disorder not a disorder after all

New Autism Research paradigm will make it treatable?

Stem Cell Research and Hopes for Cell-Based Medicine

Alex Soojung-Kim Pang — Tue, 23 Oct 2007 11:10:30 -0700

Description

Stem cell research is likely to lead to a new kind of cell-based medicine that regenerates the body, but practical and ethical challenges mean safe and effective treatments may be decades away.

Stem cells are undifferentiated cells that have the potential to develop into other more specialized cells. Stem cells are found in adults in the bone marrow, but also in embryos. While adult stems cells have been used to treat disease for several decades in bone marrow transplants, it is the progress in embryonic stem cell research that has been the source of great therapeutic hope, ethical and legal controversy, and international competition.

Unlike adult stem cells, embryonic stem cells have the potential to become any other kind of cell, which is the key to the intense interest. Novel therapeutic treatments could potentially be applied to every system in the human body. Possibilities include replacing malfunctioning liver cells or even growing entire livers to replace diseased ones, therapies for Parkinson's and Alzheimer's diseases, spinal cord injury, stroke, cancer, burns, cardiovascular disease, diabetes, osteoarthritis, and rheumatoid arthritis.

Interest in developmental biology, health and disease, medical economics, and national pride are all driving forward this relatively new research area. The technical challenges of acquiring and working with embryonic stem cells in a laboratory environment are significant but nevertheless, important breakthroughs are beginning to occur and progress in research practices in the next 5 to 10 years is possible. Practical applications of embryonic stem cell research however are likely to be decades away. Much more biological knowledge is needed before an embryonic stem cell can be guided and controlled into developing into just the right specialised, viable, and stable cell. The economic potential however is leading to immediate investment by biotechnology companies.

Because the research relies on using tissue from aborted fetuses, this research raises a number of moral, religious and political concerns about the sanctity of embryos and the use of fetal cells, as well as an uneasiness about cloning and hybridisation of species. A complicated set of rules, guidelines and practices has developed across nations, leaving considerable room for individual countries to respond to the views and concerns of their population. As a result of this lack of consensus, advances in stem cell research are most likely to be made in geographic areas with less restrictive legislation. Currently, China has the most permissive environment for research with little opposition, while the UK is a Western leader, with a strong scientific research pool and a relatively supportive public. The US restricts the flow of federal money for research but places no bans on private, state, or local government funding and American opinion fluctuates but on average is evenly divided over the issue of federal funding for stem cell research."

This will be enabled by:

"Technical improvements in handling and culturing of embryonic stem cells
Continuing lack of alternative therapies for fatal diseases
Resolution of ethical debates about the cloning and use of human embryonic stem cells and standardisation of regulations
Increased government funding driven by international competition
Greater investments from venture capitalists who are currently waiting for resolution of legal, regulatory, and medical issues"

Early indicators include:

"Development of dedicated research institutions at universities, such as the Harvard Stem Cell Institute (which has raised $30 million from foundations and private donors and is creating its own stem cell lines) and the Cambridge Stem Cell Institute (which has raised £16.5 million and plans to raise a further £33.5 million over the next five years to further its mission to 'deliver therapies in regenerative medicine at the earliest possible date')
Geron's intention to apply for FDA permission to conduct clinical trials of cells for a spinal therapy
Stem Cell Science's work on developing a treatment for Batten disease, a fatal brain disease
Public support of research by celebrities such as Michael J. Fox, Nancy Reagan, and Christopher Reeve in hopes of treatments for Parkinson's disease, Alzheimer's disease, and spinal injury
The South Korean government's issuance in February 2005 of a postage stamp in honor of Dr. Hwang Woo Suk, a pioneer of embryonic stem cell research, and its allocation of $43 million to build Dr. Suk a stem cell research centre
Passage in November 2004 of a California bill allocating $3 billion over 10 years to stem cell research"

What to watch:

Stem cell researchers become concentrated at centres focused on biomedical applications.
An international statement is issued on the ethics and practices of stem cell research encouraging a more permissive research environment.
The number of viable embryonic stem cell lines routinely used in research increases rapidly.
Large clinical trials testing treatments for incurable degenerative diseases are initiated.