PROFESSIONAL ETHICS REPORT

U.S. States

Currently, two state laws specifically promote embryonic stem cell research.  California is one, and its laws allow for the creation of embryos by SCNT.[8]  Proposition 71 “authorizes tax-free state bonds that will provide an average of $295 million per year over ten years to support stem cell research at California universities, medical schools and research facilities.”[9] The vote on this ballot initiative will take place in November 2004.

Other states are deciding whether to ban, allow, or restrict the research, and many bills have been introduced on the topic.[12]  The National Conference of State Legislatures reports that current state laws are very diverse, and some states restrict research activities based on the source of the embryo.  An example of a highly restrictive policy exists in South Dakota, which bans embryo research completely.[13]  In the absence of broader federal funding, state action, especially in states with the resources and facilities to conduct research, may prove to be essential in allowing U.S. scientists to do what is often permitted abroad.[14]

The Political Climate in the U.S.

The stem cell debate has permeated politics and become an election-year issue.  President Bush has stood by his original decision.  The moral status he accords to human embryos shapes his view that thegovernment - via federal funding - should not be complicit in their destruction.[15] The Democratic nominee, John Kerry, has pledged to overturn the ban on federal funding of new cell lines.[16]  Finally, Ron Reagan, son of the late President, has publicly declared his support for stem cell research, as he watched his father fade irreversibly from Alzheimer’s disease.  It would be useful to know the extent to which U.S. researchers have diverted research interests from embryonic stem cells in order to pursue other, fundable projects.  Anecdotal evidence suggests that researchers relocate to pursue their work where the policies are more permissive,[17] and within the U.S., researchers will likely be attracted to New Jersey and California (especially if the people of California vote for Prop. 71).  However, statistics describing this potential trend could prove useful to evaluate the effects of current state and federal policy. 

Public Education

A Lancet editorial encourages scientists to engage in public dialogue about stem cell research.[18]  Members of the public undoubtedly have been exposed to a variety of views. The media, politicians, and those with personal stories, such as activist Christopher Reeve, help to shape the public’s perception of science and its potential benefits.  However, claims that the technology could be used to produce clones for spare body parts likely infuse fear and skepticism into public opinion.  Public education is the key to not only alleviating fears of scientists’ intentions, but also for explaining the use of embryos in this research in terms the public can understand and appreciate, whether or not their tax dollars will help fund the work. 

A Personal Perspective

Currently, embryonic stem cell research is young but promising.  Private and state funding and the available stem cell lines may be adequate for the time being.  However, if the U.S. is to be on the cutting-edge of medical and scientific breakthroughs emerging from stem cell research, federal funding will likely be essential.  Scientific freedom has been invoked as a means through which stem cell policy should be examined.[19]  Despite the research conducted by Zhan, et al. (see note 4) using a federally-fundable cell line, the full promise of this team’s work relies on the premise that stem cell-based therapies will be developed.  Some suggest that the disparity between the President’s policy limiting federal funding and the fact that much can be done with private money warrants regulation of some kind, whatever it may be.[20]  I support a policy that allots federal funding to research involving embryos from SCNT and those created by IVF to increase the number and diversity of cell lines available.  Parameters would be required to ensure ethical oversight, such as protection of those donating gametes (if a policy permits use of embryos created for research purposes through IVF) or embryos left-over from IVF during fertility treatment.   

ACADEMIES LOBBY ON CLONING
The United Nations (UN) General Assembly is expected to revisit the human cloning issue once again this fall with a vote scheduled for October 21-22. [1] In anticipation of such a decision by the UN’s 59^th General Assembly, the InterAcademy Panel (IAP), an umbrella body for national science academies based in Italy, has been urging the world’s science academies to reaffirm their support for an international cloning treaty that does not outlaw cloning for research.  In hopes of stepping up the pressure on its members’ national governments, the IAP re-released a statement from last year, signed by 67 of its 90 member organizations, that urges appropriate government officials to leave policy on research cloning up to individual countries.[2]

BIO JOURNAL MISTAKENLY PUBLISHES INTELLIGENT DESIGN STUDY
In a public statement, [1] the Biological Society of Washington (BSW) is distancing itself from the pages of its own 124-year old journal, The Proceedings of the Biological Society of Washington.  Much to the dismay of the society's leadership, a paper “deemed inappropriate” by its council appeared in the June issue of its peer-reviewed taxonomy publication.

NEW REPORT ON CONFLICTS OF INTEREST STANDARDS
On 13 September 2004 a survey released by the Association of American Medical Colleges (AAMC) reported that accredited medical schools in the United States are strengthening their financial conflicts of interest standards in clinical research.  Following a AAMC publication in 2001, “Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research,” which focused on the oversight of individual financial interests in human subjects research, the survey is the second installment from the AAMC task force looking at institutional conflicts of interest in human subjects research.  

The survey collected responses over a nine month period to assess the extent to which institutional conflicts of interest policies reflect the 2001 AAMC recommendations.  AAMC reported that 95 percent of institutions that responded have a policy that applies to all human subjects research that extends beyond the minimum federal standards.  Additional findings include:

• Most institutions have elucidated their conflict of interest standards:  95 percent of which apply to all faculty engaged in human subjects research, regardless of the funding source; and 77 percent include all non-faculty engaged in human subjects research, regardless of the funding source.
• Most institutions are moving toward full disclosure:  98 percent of the respondents define a significant financial interest in their policies; 95 percent use the federal government threshold of $10,000 or a lower monetary standard; and 64 percent go beyond federal regulations to consider financial ties to equity in non-publicly traded companies regardless of value, as well as non-royalty payments not directly related to reasonable costs of research.
• Institutions are using a variety of safeguards to help manage conflicts of interest: 85 percent require monitoring of the research; 74 percent require disclosure of a significant financial interest to the human participants in the consent form, and the policies of 86 percent suggest disclosure; and 76 percent have established a standing committee on conflicts of interest.

The survey also highlighted policies and procedures that need further attention.  For instance, 40 percent of institutions do not require researchers to disclose financial interests in oral presentations; therefore, the AAMC suggests the need for more inclusive definitions of covered financial interests.  Moreover, 9 percent of standing conflicts of interest committees within institutions do not include public representatives, and 41 percent of institutions with such committees do not require the evaluation of significant financial interests prior to final IRB review.  In order for institutions to sustain credibility in the oversight and management of these processes and to maintain public trust and confidence, the AAMC feels that more public representation on standing conflicts of interest committees is needed to help safeguard research participants and institutional integrity.   

To view the survey report, see http://www.aamc.org/members/coitf/coiresults2003.pdf. Information about the AAMC is available at http://www.aamc.org.

*KA 

NIH PLACES BAN ON PRIVATE CONSULTING
In a memo to employees on September 24, 2004, Dr. Raynard Kington, Deputy Director of NIH, announced a plan to impose a minimum one-year moratorium on private consulting by all NIH scientists.[1] The proposed ban is by far the most restrictive response yet to intense scrutiny the NIH has received from both the public and Congress over high consulting fees and lack of disclosure of consulting activities by NIH scientists. The primary concern is about conflict of interest, especially among top-level NIH scientists and supervisors who have consulting ties with biotech companies as well as NIH grant-making authority. Recommendations by a Blue Ribbon conflict of interest panel convened by NIH Director Elias Zerhouni earlier this year limited the amount of compensation that could be received and the number of hours per year an employee could devote to outside consulting. In August, NIH went beyond those recommendations to ban any NIH employee with even indirect authority over NIH grants from consulting and to even further cut possible compensation for those allowed to engage in consulting activities. At that time, NIH anticipated that the new oversight system would be fully active within six months.

The guest speakers who assisted the Council in answering this question included Stephen J. Morse, Professor of Law and Professor of Psychology and Law in Psychiatry, University of Pennsylvania Law school, and Emil Coccaro, Clinical Neuroscience and Psychopharmacology Research Unit, University of Chicago.  Dr. Morse addressed the extent of neuroscience's influence on the law; while Dr. Coccaro focused on the mechanistic explanations of aggressive behavior in individuals. Both speakers agreed that law, unlike mechanistic explanations, governs humans as intentional agents and judges actions, not brain activity.  "We don’t hold brain neurotransmitters responsible---we hold people responsible," said Morse.  Neuroscience does increase our understanding of human behavior, answer some causal questions, and may influence the verdict when enough significant evidence is provided.  For now, however, with our existing knowledge, neuroscience can not dictate or determine law. *TJ

Undermining the Integrity of Scientific Analysis

The report cites several circumstances where scientific analysis within federal agencies has been suppressed or distorted. For example:

• As a result of a 1998 court ruling on mountaintop removal strip mining in Appalachia, the BA commissioned five federal and state agencies to conduct scientific studies of the issue in order to produce an environmental impact statement (EIS).  While one stated purpose of the EIS was to suggest alternative options and their implications, records show that scientists were instructed by a Department of Interior official to shift the focus of the report away from alternatives.  In addition, severity of the problem was downplayed in the final report by omitting words such as “significant” and “severe.”

• In the case of deciding whether to approve an emergency contraceptive as an over-the-counter drug, a top FDA official acted contrary to FDA protocol by overruling the advice of scientific advisory panels and FDA staff, and denying approval for the drug to be sold without a prescription.  The official defended his decision by claiming there was not enough evidence to prove the drug was safe for women aged 14-16.  In fact, two science advisory panels had determined that the drug was equally safe for younger and older women.       

Undermining the Integrity of Science Advisory Councils

The report also considers the use of political litmus tests as undermining the integrity of scientific advisory committees established by the federal government.  An example is the use of political questioning when adding or renewing members of scientific advisory panels at NIH, the National Advisory Council for Human Genome Research, the National Institute on Drug Abuse, and the President’s Council on Bioethics.  Potential advisory committee members at these organizations were questioned by BA officials regarding their like or dislike of the President and their opinions on significantly politicized issues, such as stem cell research.  Highly qualified experts were subsequently rejected for those advisory committees, according to the UCS, presumably based on positions not in line with those of the Bush Administration.

The full report can be found at http://www.ucsusa.org/global_environment/rsi/page.cfm?pageID=1449.

*LS

GENETIC POLICY AND LEGISLATION DATABASE LAUNCHED
If specific genetics-related policy and legislative documents continue to elude you, your search may be over thanks to a database recently launched on the Web by the US National Human Genome Research Institute (NHGRI).  A click on http://www.genome.gov/LegislativeDatabase  takes you just an index finger away from a clearinghouse of genetic policy, legislations, and useful links.  

The database contains federal and state laws/statutes; federal legislative materials; and federal administrative and executive materials, including regulations, institutional policies, and executive orders.  Perhaps more importantly, the database includes a summary – in layman’s terms – of each document, making it possible to skip the legal particulars and get right to the point of a document’s relevancy.  Content currently focuses on the following subject areas: privacy of genetic information/confidentiality; informed consent; insurance and employment discrimination; genetic testing and counseling; and commercialization and patenting.

According to Francis Collins, NHGRI director, the database will be useful for everybody, “from academic researchers seeking to patent genetic technologies to average citizens trying to determine what protections exist in their states against genetic discrimination.”[1]

Search tactics feature an interactive US map that highlights state-specific data, plus content type and source queries.  Keyword searching is possible for words in document titles, but not those in their full text.  The database contains only US policy and legislation.  The addition of foreign content categories is expected this autumn.     *AK

RCR RESOURCES NOW AVAILABLE ONLINE
The Office of Research Integrity has announced that the first 11 resources developed under the Responsible Conduct of Research (RCR) Resource Development Program are available on its website at http://ori.hhs.gov/html/rcreducation/ori_prod.asp.  Some of the topics covered are:

• Online RCR Study Guide
• Online Research Ethics Course
• A Guidebook for Teaching Selected Responsible Conduct of Research Topics to a Culturally Diverse Trainee Group
• Welfare of Animals
• Conflicts of Interest
• Mentoring

The Resource Development Program was launched in 2002 to facilitate the development of RCR instructional materials for use by colleges and universities, hospitals, medical schools, scientific societies, and other scientific research organizations, thus relieving them of the need to create their own. A request for proposals is issued each year, usually in September.  The next deadline for submission is February 25, 2005. More information on the RFP process is available at http://ori.hhs.gov/multimedia/acrobat/SOW%202005.pdf.

*KS

BEGINNING BIO-BUSINESS ETHICS:
A review of Margaret L. Eaton’s Ethics and the Business of Bioscience.

by Brent Garland, AAAS

The term bioscience is general, encompassing many different fields—the agricultural, genomic, and bio-chemical, among them. The practitioners of bioscience come from companies large and small, and must be prepared to address a variety of ethics issues—some unique to their field or industry sector, some common to any scientist. For scientists, the need for ethics guidance has resulted in a small industry: companies provide training programs, and a variety of books on the ethics of science and research are available. The field of bioethics has produced a great deal of work on the ethics of human subjects research alone, as well as addressing other research concerns.

But the work of scientists does not exist in a vacuum, and much of the work of bioscientists is performed with an eye to commercial production and applications. Just like scientists, the businesspeople who seek to commercialize bioscience products have to consider the ethical and social impacts of their work.

In putting together the casebook Ethics and the Business of Bioscience, Margaret Eaton seeks to assist business students (and others) in considering bioscience business decisions from within an ethics framework. Eaton addresses a range of disciplines in the volume, considers companies that vary not only in product but also in size, and outlines a variety of ethical systems to consider. For its express purpose of facilitating “instruction in the effective business management of the ethical and social ramifications of commercializing new medical and biotechnology products,” the book should serve remarkably well, though it may be of limited utility for others.

For the business student first approaching the study of ethics, the casebook is laid out in a very straightforward and sensible way. The first part of the book, and the shortest, makes the case for why one should study bioscience business ethics. Eaton notes the illustrative examples of nuclear power and genetically modified food crops as lessons on how the failure to consider social concerns can be dramatically damaging to business.

The second part of the book may well be of the greatest value for the business student or other people just beginning to consider business ethics issues. Part II opens with a brief overview of various ethics systems, and follows with examples of how ethics analysis might be applied. Though this section is unlikely to satisfy philosophers or other scholars of moral and ethical codes as sufficiently thorough, Eaton clearly lays out key ideas and principles from the most common systems of ethics, including utilitarianism, Kantian ethics, and modern theories of justice. For business students new to the subject of ethics, Eaton provides enough substance to power straightforward discussions of ethics issues.

The initial chapter in Part II is followed by a discussion of how the various ethical systems and frameworks might address the situation Monsanto faced regarding the labeling of dairy products containing recombinant bovine somatotropin (rbST), a synthetic growth hormone that stimulates milk production. The case study is presented in great detail, and a number of ethics analyses are applied, demonstrating how the choice of applicable ethics system can give rise to variations in what is identified as a problem, what might be considered as an appropriate response, and different standards for what constitutes acceptable resolution.

Eaton closes Part II of the book with two unsatisfactorily brief chapters offering primers on two complex topics: the regulation, testing and approval of medical devices and pharmaceutical products; and research ethics. The research ethics chapter addresses modern research ethics for both animals and people, and will only passably acquaint the reader with the history of modern ethics codes, including the Nuremberg Code, the Declaration of Helsinki, and the Belmont report.

The chapter on the regulation and approval of medical devices and pharmaceuticals is equally brief in laying out the stages and processes of Investigational New Drug applications, clinical trial phases, the role of Institutional Review Boards, and regulation of medical devices. While specific elements from both of the concluding chapters of this section are developed more fully in the final section of case studies, the chapters could have used more substance, and readers with an interest in either set of topics will need more information before they can begin to discuss either research ethics or drug/device approval and regulation with any degree of specificity.  

Part III, the final section of the book, provides a series of case studies in the traditional format for discussion. It should be noted that the cases are somewhat more detailed than typical, in part because Eaton has provided a snapshot of the social context in which the cases occurred, such that the relevant ethics issues, social concerns, and stakeholders can be included in one’s consideration of the case and business analysis. Eaton’s case subjects are varied by company size, industry sector and the presentation of issues—all of which should help provide students with some range in their thinking about and discussion of the cases. 

While the book has a great deal to offer, it should not be taken as a complete primer, but instead as an introductory text. The cases are drawn primarily from the 1990s, and so are relatively current, very instructive, and clearly presented. For those seeking to teach an introductory course on business ethics or to begin considering ethics issues arising specifically in the bioscience industry, this book offers an excellent single volume with which to begin.

Eaton, Margaret L., Ethics and the Business of Bioscience, Stanford, California: Stanford University Press, 2004. US$34.95 paper.