Ethics/Law/Standards/Practices
This week we will finish up with the discussion about funding, then move on to the topics below. Bring your thoughts and questions.
Politics and science
It is very easy to put science on a pedestal. We think of science in the highest terms. But, like other human beings, some scientists are not immune to the weaknesses of bias, dishonesty, and exaggeration. It should not, therefore, be surprising that science itself is susceptible to political distortion for various reasons.
Federal agencies (and private foundations) fund grants for specific purposes. Expenditure of public money (i.e., tax dollars dispensed by the government) is, in theory, tied to furthering the public good. Virtually all public money that funds research comes from legislative action. Legislators, in turn, are popularly elected. Do legislators respond to public pressure when it comes to research? Just as for any other legislative activity, people in Congress listen to the "folks back home" when it comes to science. While it is important that legislators represent their constituents in responsible ways, it means in many cases that legislators are listening to voices that are largely uninformed on the complexity of most scientific issues.
Should the public or scientists have the final word on funding government sponsored research?
Consider, for example the super-conducting super-collider project of a few years ago. This was one of the most massive science projects ever considered by the federal government. It began in the mid 1980s and involved building a massive underground tunnel, many miles long, capable of accelerating sub-atomic particles to great speeds and energies for the purpose of colliding them together to better understand what they were composed of. Initial phases of the project, funded by Congress on a ten year plan, were approved. A considerable section of the tunnel and associated structures were built. Dozens of scientists uprooted themselves and their families to Texas, where the project was being constructed so they could work on it. Then, in the midst of federal budget cutting in the early 1990s, the project was cut, primarily for two reasons - 1) the public perceived it as little more than an expensive hole in the ground and 2) the composition of Congress changed, eroding support of public funding of science in favor of privatization.
As a consequence of these circumstances, funding for the super-conducting super collider project was stopped abruptly, well before the completion of the 10 year plan. Despite earlier legislative commitments, the project was abandoned. Many millions of dollars that had already been spent were wasted, the uprooted scientists had nothing to work on and no further employment after all their efforts.
How could such a circumstance be avoided?
What sorts of scientific research funding today are complicated because of political considerations that take priority over scientific merit?
Rules of Scientific Conduct
The rules of the game in doing science
The community of scientists has many unwritten rules of conduct. Just as with the unwritten rules in any society, these are rarely explicitly discussed. Some of these rules are simply rules of courtesy and not very different from those that apply in any other field of endeavor, but some are peculiar to science. All of them provide an insight into the vision that scientists have of science as a process.
The first commandment of science is "Thou shalt not lie". That is to say, you are to be scrupulously honest and careful in carrying out your work, in interpreting it, and in communicating it.
What are some ways that a scientist might be dishonest?
There are various ways in which a scientist might not live by the first commandment of science. These range in seriousness from bias in interpreting data that leads to false conclusions (remember that bias may be unconscious) all the way to deliberate misrepresentation or manipulation of experimental data to fit a hypothesis (this is not common, but not unknown).
Why does it make no sense to be dishonest in doing science?
Since the whole point of doing science is to find out the truth about the natural world, it seems obvious that anyone who is dishonest in doing science is an automatic failure. A quote from Nobel laureate Francois Jacob sums it up perfectly: "The rule of the whole game in science is not to cheat- not to cheat with ideas, nor with facts. This is a rational as well as a moral commitment. The one who cheats in science is simply missing the point. He defeats himself. He commits suicide."
Can you think of some reasons that people
might be dishonest in doing science?
Why is honesty so important in science?
What happens if you make a genuine mistake
and find out that you were wrong after you have written and submitted
a paper for publication? What if the results have already appeared
in print?
Honesty demands that you do not conceal the mistake (and keeping quiet about it is one way to conceal the mistake, at least temporarily). It is imperative that the mistake must be admitted as soon as possible after you find out. Like all human beings, scientists will sometimes make mistakes. The important thing is to let people know that you were mistaken. Even eminent scientists from world-famous labs have had this experience, and there is no shame in admitting to an error.
What about actual cheating? What if you are
a professor or the head of a laboratory and one of the people
working for you deliberately fudges the data so that it fits your
hypothesis. You don't know that they manipulated the data, and
you are thrilled that your hypothesis held up. You rush to write
up the results and publish them, so that everyone will know of
your wonderful discovery. Perhaps, everyone in your field is excited
when they read the paper. A year later, someone else is trying
to repeat the experiments in the paper and find that they get
completely different results even though they followed the methods
exactly as described and used identical materials. You are puzzled
and decide to investigate for yourself. When you repeat the experiment
your results match those of the other lab, not the original results
reported by your graduate student. An examination of the lab books
and records then reveals that your student had deliberately altered
the data that was shown to you. What do you do?
As with the genuine mistake, your first job is to let people in
the scientific community know that the results reported are false.
In cases like this, it is customary for the head of the research
group to write a letter of retraction and apology to the editor
of the journal in which the paper appeared. The retraction will
then be published in the journal, so that anyone who read the
original paper will be warned that the results in it are unreliable.
In addition, you would need to take disciplinary action against
the dishonest student or employee. This can take various forms,
depending on the guidelines of the institution. There can also
be very serious consequences for the laboratory if an investigation
indicates that there was repeated or widespread dishonesty, or
that the principal investigator was party to the deception. In
such cases, the funding agencies that supported the researcher's
work may withdraw their grants and bar the person from applying
for new grants for an extended period of time. The institution
may also take disciplinary action, as appropriate. Of course,
in addition to this, the reputation of the laboratory and its
head will suffer. In a field where the respect and recognition
of peers is the highest reward, this loss of credibility can be
personally painful and professionally disastrous.
Consider the following situation - A researcher accepts a grant and then publishes a paper on research done using the grant money in which a member of his/her lab has stolen or altered data. The problem is revealed. What is the responsibility of the researcher and the researcher's institution to the granting agency for potential misuse of grant funds? How does the responsibility change if it is the grant recipient (i.e., the professor) involved in the fraud instead of a member of the lab?
How can a lab director guard against the occurrence of such dishonesty?
The second commandment
of science is "Thou shalt share thy information and thy materials".
What exactly does this mean?
Since science is a collective venture, that is, it advances by
the accumulation of discoveries made by many people, it seems
obvious that scientists would need to share information. This
is accomplished, most obviously, by publishing results in scientific
journals, but also, more informally, by scientists talking to
each other, often about work in progress. There is an amazing
amount of give and take in these conversations, and scientists
depend greatly on brainstorming with their colleagues to come
up with creative solutions to problems.
On another level, there are huge databases that contain information
such as DNA or protein sequences or structures. These databases
are compiled from the information submitted by individual labs
as they determine a sequence or solve a structure, and they are
freely available to any scientist anywhere in the world. Many
scientific journals will not publish a paper unless the authors
agree to make their materials, such as clones or antibodies, available
to other scientists in the field. Likewise, for a paper to be
accepted for publication, the sequence of the gene or protein
under study must first be submitted to one of the public databases
and an accession number obtained. This policy ensures that any
scientist interested in the information will be assured of access
to it.
An exception to this rule regarding information sharing is the work of scientists employed by the research and development divisions of corporations. Companies usually have restrictions on the information and materials that their employees may share with other scientists. This is not surprising given that they are not in business for the good of the community but to make profits. Scientists working in labs in industry often are not permitted to publish their results until the company has given them permission to make the findings public. However, these same industry scientists can, of course, benefit from and use the findings of those who work at universities or other government funded institutions, because those findings are in the public domain. This is an important point to remember when companies claim that they should be allowed to charge high prices for their products because they spent a lot of money on research and development. These companies have used the findings of countless scientists funded by the tax-payer, because publicly funded science is an open arena. The tax-payer is thus paying for research that corporations then profit from.
The third commandment
of science is "Thou shalt not take unfair advantage of the
generosity of other scientists".
There are reciprocal, unwritten rules of courtesy governing the
use of the information or materials donated by another lab. The
standard practice is to write a letter requesting the materials
and explaining clearly what you wish to do with them. It is also
courteous to make certain that the experiments you plan are not
in conflict with those of your donor lab. It is inappropriate
to request a clone from a laboratory in order to carry out the
very experiments that they had planned to do next. If they are
expected to part with materials that may have taken much time
and effort to obtain, it is not ethical to take unfair advantage
of their generosity. Materials or information obtained from another
research group must always be formally acknowledged in any paper
that reports on results obtained using those materials.
This last rule highlights one of the aspects of science that non-scientists do not often understand. Scientists, usually, do not make a lot of money from doing science. The reward in doing science is generally personal satisfaction in discovering new things. The nature of science dictates that even this new discovery does not "belong" to the scientist, but must be freely shared with the scientific community. This means that the main reward that a scientist can hope for is the recognition that comes from being the first to make the discovery. If someone tries to steal even that reward by misusing freely shared materials, it deprives the scientist of the hard-won recognition and respect that is rightfully his or hers. This is one of the reasons that you will sometimes see in the acknowledgments section of a scientific paper, a sentence that says, " We wish to thank Dr. Braino for useful discussions and insightful suggestions", or words to that effect. Here, the authors of the paper are acknowledging the intellectual input of Dr. Braino, who may have helped them in interpreting their data or in coming up with a good idea. By acknowledging Dr.B, the authors are giving credit where credit is due. Using someone's ideas and failing to acknowledge their intellectual input is unethical as well as extremely bad manners.
Peer Review
It is often said that science is only as good as the people who do it. We have seen that civil debate, questioning, and unusual or unpopular ideas are important components of scientific progress. Science, as it is practiced, requires a greater tolerance of unusual ideas than exists in the public at large. Consider, for example, that what we think of as scientific fact arises from debate of numerous alternatives among experts in a particular field.
We remember that it is impossible to prove anything absolutely, however. It is possible, therefore, that a person(s) might support an idea solely for the purpose of opposing another idea and can cling to it forever, if they choose, because no idea can be "absolutely proven". This is the approach taken by some non-scientists (and even some scientists with particular agendas- remember there are scientists who are paid by the tobacco industry or by General Motors) with respect to such topics as evolution, global warming or the question of whether tobacco smoking is bad for health.
Widespread misunderstanding of the nature of science (scientists are usually very careful not to claim "proof") leads to confusion in people's minds about what scientists mean when they argue about evidence. If scientists argue about the details of something like evolution it doesn't mean that they doubt that it is happening, it just means that they are trying to clean up the details of how it occurs (it also means that scientists like to argue- or they wouldn't and shouldn't, be scientists). The non-scientists' lack of familiarity with the process of science is exploited by dishonest people who point to such arguments as evidence that science has not reached a consensus on the occurrence of climate change or evolution, when what is being debated is the mechanism of such change.
Because of the complexity and diversity of science and the difficulty in anyone fully understanding the scientific merits of broad areas of science, we rely on so-called peer review of important scientific matters, such as publishing results in journals and funding of grant proposals. We have earlier discussed the grant review process, in which scientists who are experts in the field of the proposed research review and recommend funding of grants. Similarly, scientific journals rely on expert review of scientific papers submitted to them for making decisions about whether a particular paper is worthy of publication or whether it should require additional work.
Politics, bias, and personality issues can, of course, enter into any human decision. Similarly, unpopular ideas may find few supporters, but may, nevertheless, prove correct. Consider Barbara McClintock, who, in the 1940s and 50s discovered a new type of genetic element that appeared to "jump" around. She correctly identified it as a mobile genetic element (now known as a transposon), though conventional wisdom of the time was skeptical that such a thing could exist (remember that even the structure of DNA had not been elucidated at this time). Nonetheless, she persisted in her interpretation of her data, because it clearly contained a message that was not readily explained by existing theory. Though the significance of her findings were not recognized, her research projects were, nevertheless, funded because her ideas were not inconsistent with her data, even though they were contrary to what people thought at the time. This is a very important point: in reviewing scientific proposals and papers, scientists rely on data in making decisions. McClintock's data seemed consistent with her ideas, so though her interpretations did not make sense in light of what was known then, her work could not be dismissed. Note also (that contrary to some present day accounts of her career) McClintock was actually highly respected by the scientists of her time, even if they disagreed with her ideas. She was elected to the National Academies of Science in 1944, and named President of the Genetics Society of America in 1945.
Intellectual Property
A common word one hears today associated with the biotechnology industry is "patent". A patent is a greatly misunderstood term for a governmental mechanism to aid inventors. Patents are granted by governments to inventors solely for the public good - to encourage development and use of inventions. A patent guarantees to the owner(s) of the patent that, for a span of 20 years (starting from the filing date), they have sole rights to determine how their invention is used. Patents are similar to copyrights in assigning rights to creators, but differ in what is protected (an invention vs. a creative work) and the period of time of protection (20 years for patents vs. lifetime for copyrights). In exchange for this protection, the content of the patent/copyright becomes publicly available so that others can use and develop products relating to it or derived from it.
Further, after the patent/copyright expires, the work becomes available to the public for free use. Most of us have heard of generic drugs, for example. These are drugs for which the patent has expired and other drug manufacturers have stepped in and started making the drug, due to the lack of patent restrictions. While the patent is in place, only the patent holder could assign rights as to who could make and sell the patented drug. A recent example of an expired patent was that of the cork-soled sandals made by Birkenstock. Till a few years ago, the patent for shoes with a particular kind of cork soles was held by Birkenstock, who made and sold the sandals exclusively (for a pretty penny). When the patent expired, a flood of cork-soled shoes patterned on the Birkenstock model, made by many different companies, were suddenly available for a third to a quarter of the price of the originals. Although Birkenstock still makes and sells its high priced sandals to die-hard loyalists, the company has diversified its offerings because it can no longer count on people paying a hundred dollars for sandals they can get elsewhere for twentyfive bucks.
The patenting process can be a long and costly one ($500 to $50,000). When costs associated with testing of patented items (such as drugs) are factored in, patent costs may total many millions of dollars. Patents cover items, such as inventions (CD ROMs, for example) or processes, such as PCR, the making of a novel organism, or ways to isolated genes. For the biological sciences, patents can also covers things like DNA sequences, if the sequence is derived in a novel fashion, it is new, and if a use for it is clearly described. For a patent to be awarded, it must meet three requirements - 1) it must be novel and not common knowledge, 2) it must work as claimed in the patent application, and 3) it must not have been done previously by others.
Patents are rooted in "claims" that inventors make about their invention. The inventor(s) of the wheel, for example, could have made the claim that it was a labor saving device for helping to haul rocks in ancient times, but unless they claimed it as a way of moving a vehicle when linked to an axle (a broader claim), they would not be able to stop chariot makers from using it for that purpose. Patent applications, therefore are full of claims the inventors make about their invention so as to be as broadly protected as possible in the patent that is finally issued. Patent examiners, therefore, have to not only check that the patent meets the three requirements above, it must also determine if the inventor should be protected for all of the uses of the patent as claimed in the application.
It can take several years between the first application for a patent and the final award (or disallowance) of a patent. Even after it is awarded, a patent can be challenged in court on the basis of some failure of the patent to meet the three requirements or on the basis of too broad of an award compared to the claims.
FAQs about patents
(from - http://www.uspto.gov/web/offices/pac/doc/general/faq.htm)
l. Q. What do the terms "patent pending" and "patent
applied for" mean?
A. They are used by a manufacturer or seller of an article to inform the public that an application for patent on that article is on file in the Patent and Trademark Office. The law imposes a fine on those who use these terms falsely to deceive the public.
2. Q. Is there any danger that the Patent and Trademark Office will give others information contained in my application while it is pending?
A. No. All patent applications are maintained in the strictest confidence until the patent is issued. After the patent is issued, however, the Office file containing the application and all correspondence leading up to issuance of the patent is made available in the Files Information Unit for inspection by anyone and copies
of these files may be purchased from the Office.
3. Q. May I write to the Patent and Trademark Office directly about my application after it is filed?
A. The Office will answer an applicant's inquiries as to the status of the application, and inform you whether your application has been rejected, allowed, or is awaiting action. However, if you have a patent attorney or agent of record in the application file the Office will not correspond with both you and the attorney/agent concerning the merits of your application. All comments concerning your application should be forwarded through your attorney or agent.
4. Q. Is it necessary to go to the Patent and Trademark Office to transact business concerning patent matters?
A. No; most business with the Office is conducted by correspondence. Interviews regarding pending applications can be arranged with examiners if necessary, however, and are often helpful.
5. Q. If two or more persons work together to make an invention, to whom will the patent be granted?
A. If each had a share in the ideas forming the invention, they are joint inventors and a patent will be issued to them jointly on the basis of a proper patent application. If, on the other hand, one of these persons has provided all of the ideas of the invention, and the other has only followed instructions in making it, the person who contributed the ideas is the sole inventor and the patent application and patent shall be in his/her name alone.
6. Q. If one person furnishes all of the ideas to make an invention and another employs him or furnishes the money for building and testing the invention, should the patent application be filed by them jointly?
A. No. The application must be signed by the true inventor, and filed in the Patent and Trademark Office, in the inventor's name. This is the person who furnishes the ideas, not the employer or the person who furnishes the money.
Science and the Law
Besides purely ethical considerations about the conduct of scientists and scientific research, there are legal ones as well. Just as in the rest of the world, it is almost impossible to simultaneously consider all of the possible legal concerns in scientific research. Consider how the following issues might affect scientists from the standpoint of law:
1. Stem cell research
2. Abortion-related research/contraception (e.g., RU 486)
3. Assisted suicide/euthanasia
4. Patent infringement
5. Release of bio-engineered organisms
6. Sale of bio-engineered food
7. Forensics
8. Drug side-effects
Some Relevant Web Sites:
Bioethics.net - http://www.bioethics.net/
National Bioethics Advisory Commission - http://bioethics.gov/
Science Ethics Resources on the Net - http://www.csu.edu.au/learning/eis/ethxonline.html
Science Freedom, Responsibility, and Law -
http://www.aaas.org/spp/sfrl/projects/database/dbstate.htm
http://www.aaas.org/spp/yearbook/chap16.htm
http://www.aaas.org/spp/yearbook/chap4.htm
Human Genome project and Ethics
http://www.aaas.org/spp/sfrl/projects/hgdp/audio.htm
Patents
Patent Law for non-lawyers: http://www.dnapatent.com/law/index.html