Purpose of Presentation

• Presentation surveys 5 models of public consensus formation to identify what features insure collaborative and democratic process
• Presentation assumes that decisions regarding biotechnology, especially in the areas of human reproduction and agriculture, should be the made on the basis of broad, public consensus.

Five Models of Consensus Formation

• Minnesota: The Jefferson Center Citizen’s Jury

Process – www.jefferson-center.org

• Massachusetts: The Loka Institute’s Citizens’ Panels

www.loka.org

• Denmark: 

Consensus Conferences

• Iceland: deCode Genetics and the Icelandic

Healthcare Database

• Michigan: Genome Technology & Reproduction

Values & Public Policy Project

Jefferson Center for New Democratic Processes

• Non-profit; established 1974
• Mission: To strengthen the democratic process by providing decision-makers with tools to assess more effectively and comprehensively citizen opinion on issues of public significance
• See www.Jefferson-center.org

The Jefferson Center’s Citizen’s Jury Process

• Format: randomly selected and demographically representative panels of citizens meet for 4 or 5 days to examine an issue of public significance
• Jury composition: 18 individuals
• Renumeration: jurors are paid a stipend
• Planning time: 3-4 months

Elements of the Citizens Jury Process 

• Advisory Committee
• Telephone Survey
• Jury Selection
• Witness Selection
• Charge
• Hearings
• Recommendations

Advisory Committee

• The Advisory Committee is composed of individuals knowledgeable on the topic who represent a range of perspectives. They provide advice concerning the charge, agenda, and witness selection. The Advisory Committee also helps the project staff avoid bias throughout the project.

Telephone Survey

• A high quality telephone survey is conducted to randomly selected individuals in the given community (city, school district, county, state, nation). All survey respondents who agree to receive additional information are entered into the jury pool. The survey can also be used to establish base-line attitudes and demographics of the community, if needed.

Jury Selection

• The jury is carefully selected to create a microcosm of the public that reflects community demographics and attitudes regarding the topic.

Witness Selection

• Individuals knowledgeable about the issue serve as witnesses.
• These individuals provide background information and in-depth information about various aspects of the issue.
• The expert witnesses are selected to represent a variety of perspectives and opinions.

Charge

• The charge is the task facing the jury.
• It typically takes the form of a question that the jurors address and answer during deliberations.

Hearings

• Over several days of professionally moderated hearings, the expert witnesses address key issues, respond to questions and engage in a dialogue with the jurors.
• The jurors deliberate together and answer the charge.

Recommendations

• On the final day of the moderated hearings, the jury issues its findings and recommendations in a public forum.
• The recommendations appear in language that the jurors themselves develop and approve.

Evaluation

• At the conclusion of the project, the jurors are asked to complete an evaluation.
• This serves to assure the general public that the process was unbiased.
• This is important if the general public and decision-makers are to trust and respect the recommendations and outcome of the jury.
• The results of the evaluations are included in the final report.

Track Record

• 26 Citizens Jury projects since 1974 (local, state, national levels)
• Topics addressed include environmental issues (1996) and national health care reform (1993).
• Similar projects conducted in Great Britain, Germany, Denmark, Spain, and Australia.

The Loka Institute

• Non-profit, research/advocacy organization concerned with the social, political, and environmental repercussions of science and technology
• Concerned with “Community-Based Research” (CBR), research conducted by, with, or for communities (e.g., with civic, grassroots, or worker groups throughout civil society)
• More information: www.loka.org

How to Find the Loka Institute

Dick Sclove
Founder & Research Director
The Loka Institute
P.O. Box 355
Amherst, MA 01004-0355

http://www.loka.org
resclove@amherst.edu (personal)
loka@amherst.edu (Loka Institute)

(413) 559-5860 (phone)
(413) 559-5811 (fax)

Characteristics of CBR

CBR differs from the bulk of the research and development conducted in the U.S., most of which ($170 billion/year) is performed on behalf of business, the military, the federal government, or in pursuit of the scientific and academic communities’ intellectual interests.

Examples of Community-Based Research

• JSI Center for Environmental Health Studies (Boston), The Good Neighbor Project (Cambridge), Childhood Cancer Research Institute (Worcester)
• See “Community-Based Research in the United States” by R. E. Clove, M. L. Scammell, and B. Holland (July 1998).

Findings Regarding CBR

• CBR differs from mainstream research inasmuch as it is coupled with community groups that are eager to know the research results and to use them in practical efforts to achieve constructive social change
• CBR is defined by collaboration with grassroots and other non-expert groups

CBR is Underutilized

• CBR is underutilized – there is significant unmet demand for CBR. Community research centers deny requests for research assistance because of resource constraints and because the requests often do not fall within a center’s mission.
• CRB is underfunded – the U.S. and the Netherlands each spend about $10 million annually on CBR, but that means that on a per capita basis, the Dutch are investing at 15 times the U.S. rate.
• CBR in the U.S. would cost $450 million/year to match the Dutch.

The Loka Institute’s Community Research Network

• Since 1995, the Loka Institute’s Community Research Network (CRN) initiative has organized a national planning conference on CBR scheduled for June 11-13, 1999 in Amherst, MA.
• CRN also has created a national and international Internet discussion forum for CBR, published a reader, and designed a searchable Internet database of community research centers worldwide.
• Loka’s effort has inspired efforts to establish community research centers in Canada, Israel, and South Korea.

Loka Institute’s Citizens’ Panel

• In April 1997, The Loka Institute and several institutional partners organized the first U.S. participatory Citizens’ Panel to deliberate complex, controversial issues in science and technology policy
• The Citizens’ Panel was modeled on the Danish-style “consensus conference” was held in Boston
• Panel addressed “Telecommunications and the Future of Democracy”
• Reports available in Technology Review, Aug/Sept 1997, p.5 and at http://www.loka.org/pages/panel.htm

Similar Initiatives Elsewhere

• Citizens’ Panels have been organized about 35 times in 12 different nations; see http://www.loka.org/pages/worldpanels.html

Consensus Conferences (Denmark)

• The Danish Board of Technology, a quasi-independent agency of the State, originated the “consensus conference” concept.
• 18 such events have been held in the past 12 years
• See Richards Sclove’s report at http://www.loka.org/pubs/techrev.htm
• See Danish Board of Technology’s web page at http://www.tekno/dk/eng/index/htm

Contact Information for Danish Consensus Conferences

• For more information, please contact Mr. Jan Ejisted, Communications Director, Danish Board of Technology, je@tekno.dk

Danish Consensus Conference on Genetically Engineered Foods

• Held from March 12-15, 1999 and summarized by Bereano – www.loka.org/pages/DanishGeneFood.html
• 14 citizens were selected, reflecting the Danish population in terms of gender, age, etc.
• Citizens met with Danish Board of Technology planning committee, which selected readings for the citizens
• Planning committee selected a group of experts and stakeholders representing different points of view (e.g., representatives of biotech companies, research organizations, government agencies, Greenpeace, and NOAH, an organization of Danish scientists committed to social responsibility)

Consensus Conference Format

• Citizens were able to augment both the selection of experts and the educational materials.
• The moderator for the citizens’ panel was from a consulting firm.

The Dialogue: Friday-Sunday

• Experts made 15-20 minute presentations to the panel
• An audience of 150 was present
• The citizens, working with the planning group, had highlighted 10 major questions (with subdivisions) for the experts to address
• Each expert was asked to address 1-2 of these questions

Citizens’ Panel Report

• After two days of hearing reports and asking questions, the panel deliberated and formulated non-binding policy recommendations.
• On Sunday, the lay panel members prepared a written report
• On Monday, members of the panel presented the report at a national press conference (English summary at http://www.tekno.dk/eng/publicat/genfoods.htm)

Some Findings of Report on Genetically Engineered Foods

• Panel advocated strict regulation and control of the genetic engineering of foodstuffs
• Panel called for broad labeling requirements to guarantee consumer choices and for the public regulation of monopolies in the field
• Panel called for the clear separation and the protection of organic farming from farming that uses genetically engineered plants
• Panel called for the maintenance of seed banks that would preserve diverse food plants
• Panel called for an international convention to allow the Third World to use patented plants and plant materials and a legal rule that would categorize unworked patents as abandoned.
• Panel called for more public funding that would increase the competence of government authorities to oversee this technology
• Panel supported the establishment of an insurance fund, supported by industry contributions that would assure that liability for accidents would result in compensation.

• Panel asked for the establishment of an ethical committee whose deliberations would receive weight equal to that given to technical considerations.
• Panel, in keeping with the Danish tradition of social ethics, recommended that ethical committee be organized around explicit group and community values, e.g., social solidarity, social equity, etc.
• Panel held that industry should have the burden of proof to prove usefulness.

Response to Report

• The experts then had a chance to comment on the report to eliminate ambiguities and to assist the panel in reducing misunderstandings.
• Parliamentarian Jorgenson, a Social Democrat who chairs the Danish Parliaments’s Committee on Food commented on report.
• Jorgenson agreed that broader social values going beyond objective risk measures should be considered.
• Jorgenson also agreed that genetically modified foods should be particularly regulated and he was very supportive of labeling.
• Jorgenson argued that choice is not limited solely to the produce one wishes to buy but rightfully includes the process by which the products are produced.
• For more information, see Loka Alert 6.2 (20 May 1999) available from loka@amherst.edu

deCODE Genetics (Iceland)

• In 1997, Kari Stefansson, native of Iceland and geneticist formerly at Harvard, founded deCODE Genetics in Reykjavik – www.decode.is
• deCODE Genetics is a subsidiary of deCODE Genetics, Inc., which was registered in Delaware in August 1996 (Delaware offers simple and quick incorporation procedures, flexibility in corporate names and taxes)
• deCODE Genetics employs 200+

deCODE Genetics in Reykjavic 

• deCODE Genetics offers the following services:
• Gene searches
• Research equipment and genetic testing
• Genetic-based pharmaceutical research
• Access to depersonalized health data from a database
• deCODE’s analytic approached compares the DNA of healthy and diseased individuals and identifies the differences between them to detect the gene or set of genes responsible for the disease.
• Researchers begin with the physical characteristics of a disease and work back to its genetic basis.
• This is accompanied by looking for an association between known genetic markers and a specific disease.
• Once a marker with a specific form has been found to exhibit a higher than average association with the disease, the DNA located near that marker is analyzed to identify neighboring genes.
• Eventually, the disease-causing gene is identified from this location.

Some Icelandic History

• Iceland’s people descend from the Vikings who settled the island more than 1100 years ago.
• Iceland’s isolation makes Icelanders a genetically homogenous group
• The value of this homogeneity is that it took deCODE just 3 months (instead of an industry average of 15 years) to locate the gene for familial essential tremor, a hereditary disease that causes shaking in 5-10% of the world’s elderly population
• Several cataclysmic events produced “genetic bottlenecks” in Iceland:
• In the 1400s, bubonic plague cut the population from 70,000 to 25,000.
• In the 18^th century, disease/famine caused population to fall below 50,000 on three separate occasions.
• Iceland has had centralized health care since 1915.

deCODE Genetics and Foreign Capital

• DG formed a research agreement with Hoffmann-LaRoche Ltd. (Basel, Switz.) in Feb. 1998 to provide deCODE with $200 million over 5 years to study 12 common cardiovascular, neurologic, and metabolic diseases.
• HLR will hold exclusive right to any drugs or diagnostic devices developed from the research, but they will provide these products to Icelanders free of charge.

Icelandic Government Favors Influx of Foreign Capital

• High-level Support: Iceland’s Prime Minister, Mr. David Oddson, said “I view this agreement as a huge step towards securing high technology industries as important role in the Icelandic economy. The government of Iceland will do its best to assist the two parties in the agreement to achieve the goals of this collaboration.”

deCODE Genetics’ “Icelandic Healthcare Database”

• As part of its venture with HLR, DG plans to gather clinical records, family histories, and DNA for most of the nation’s 277, 000 people.
• In March 1998, DG helped to formulate a bill introduced into the Icelandic Parliament (Althingi, est. 930 as the world’s oldest legislative body) that would allow for the formation of a large, centralized healthcare database.
• From March 1998 to December 17, 1998, when the bill passed at the 123^rd session of the Icelandic Parliament), a battle raged in Iceland over the contents of the bill.

Act on a Health Sector Database no. 139/1998

• Text of Bill available at the homepage of the Icelandic Ministry of Health and Social Security (http://brunnur.stir.is/interpro/htr/htr.nsf/pages/gagnagr-ensk)
• Art. 1: authorizes the creation and operation of a centralized database of non-personally identifiable health data with the aim of increasing knowledge in order to improve health and health services

Art. 3 of Act on Health Sector Database

• Defines a “health sector database” as a collection of data containing information on health and other related information, recorded in a standardized systematic fashion, on a single centralized database, intended for processing as a source of information.
• Information will be made non-personally identifiable by “one-way coding,” which involves the transformation of words or series of digits into an incomprehensible series of symbols that cannot be traced by means of a decoding key.

Art. 4 of Act on Health Sector Database

• Grants an operating license and payments by licensee to this database; conditions for operating license include that the database is located exclusively in Iceland and that its security standards meet the requirements of the Data Protection Commission.

Before the Vote

• Before the bill was voted on, a group of Icelandic physicians made a plea to the board of directors at DG to reconsider its actions.
• In this plea, they cited severe criticisms of all or parts of the bill by 30 Icelandic ethical and scientific associations (e.g., the Icelandic Medical Association, the Data Protection Commission, the former Director of Public Health, the Genetics Committee, three national ethics boards, various geneticists and physicians, etc.).
• Mannvernd (an association of scientists and medical researchers established in October of 1998) is critical of DG’s plan.
• The Bill Passed 37 to 20

Database Licensing

• Two bids for constructing the database were opened on 4/28/99; on 5/4/99, the Icelandic government announced it would enter into negotiations with DG.
• DG probably will receive the exclusive 12-year license to create, operate and market the centralized database (a new Icelandic government currently is being formed, which may have delayed licensing).
• DG will offer access to its database to health care companies such as health-maintenance organizations interested in designing treatments for patients based on their genetic compositions.

DG’s “Icelandic Healthcare Database” will combine data from 3 databases

1. Database of healthcare records
2. Database of genealogical data
3. Database of genetic information

Database of Healthcare Records: Presumed Consent

• Data is being collected via “presumed consent,” meaning individuals need to sign out using special forms if they do not wish to participate.
• Kari Stefansson, CEO of DG, argues that he does not accept the position agreed upon by the American Society of Human Genetics that informed consent should be the norm (see John Hodgson’s article in Nature Biotechnology, Nov. 1998, pp.1020-1021)

Opting Out of Database of Healthcare Records

• According to the law, living persons only can opt out “unconditionally” until June 17, 1999, which means they can prevent their past and future records from being entered into the database.
• After June 17 and until the database begins operation, people can prevent their past records from being entered while retaining the right to enter future records.
• But once the database has commenced operation, people can only prevent future data from being entered; they will have lost control over their past records.

Responses to Health Record Database

• On April 29, a poll of persons 18+ in the newspaper Dagur claimed that 11.6% of those taking sides claimed they intended to opt out.
• 25.7% of those polled feared that the information may be abused.
• 20% of those polled were undecided or did not respond.
• As of April 21, 3000 people had opted out.

Database of Genealogical Data: Presumed Consent

• Data is being collected via presumed consent; DG has this information from 600,000 Icelanders, some of whom are no longer living.
• Genealogical data is already considered to be in the public domain in Iceland, so this component of the project is considered less problematic.

Database of Genetic Information: Informed Consent

• DG began collecting DNA samples in 1996
• Informed consent is used to obtain this information
• DG currently has this genetic information from approximately 10,000 Icelanders.

Criticisms of the Overall Database

• Critics contend that DG had too much influence in drafting the bill, and that only at the last minute did they add a clause allowing them to link the database’s medical information to existing genealogical records and to genetic information that the company collects in its own studies.
• In Jan. of 1999, 44 general practitioners and 109 hospital specialists had pledged not to send information to the database unless a patient specifically requests then to do so.

Potential Problems with Consent and the Database

• The guidelines of the European Data Protection Act from the European Parliament and Council are explicit about the issue of informed consent for participation of human subjects in gathering and storing information.
• The Icelandic parliament has ratified these collective European agreements and hence sought to legislate within them.
• The Icelandic law provides for protection of the rights of privacy regarding disclosure of information, which some claim obviates the need for informed consent.

Potential Problems with Presumed Consent

• The Icelandic healthcare database may be appealed to the European courts, where it will be determined if it is within the context and spirit of the law.
• See “The Assent of a Nation,” by Melvin McGinnis and John Hopkins, forthcoming in “Clinical Genetics.”

Controversy in Iceland

• After the outcry, Karl Stefansson attended town meetings in all communities with > 300 residents.
• Stefansson defends the database in “Opportunity, not Exploitation: Valuing the Icelandic Genome,” which appeared in Drug Discovery Today 3(8): 355-357, 1998.
• Critics charge that DG actually tried to avoid public discussion by introducing the first version of the database bill in March 1998 at the end of the legislative session, hoping to push it through parliament with a minimum of debate.

Scientists Speak Out

• The bill was stopped and controversy became public when four prominent Icelandic scientists (Helga Ogmundsdottir, Jorunn Erla Eyfjord, Gumundur Eggertsson, and Tomas Zoega) sent a letter to “Nature Biotechnology” (vol. 16, June 1998, p.496) calling attention to the matter.
• The Icelandic Mental Health Alliance (IMHA) posted a worldwide alert to the Internet, which generated much news group discussion.

To What Extent is the Data “Anonymous?”

• DG claimed that personal information in the database will be anonymous, by which they mean that names and ID’s will be eliminated.
• The database will include encrypted ID’s that critics charge can be used to trace individuals
• See report by Anderson, available at http://www.cl/cam.ac.uk/~rjal14/iceland/iceland.html

Will the Data be Misused?

• Critics contend that the Icelandic database bill sets a precedent of how medical and genetic databases in other countries could be constructed and misused in the future.
• See articles in the Economist (Dec. 5-12, 1998) and New Scientist (Dec. 5, 1998).

Was Decision-Making Democratic in Iceland?

• Critics charge that the so-called democratic public debate could have had a more productive tone if DG had been more respectful of its critics.
• Critics charge that DG overwhelmed the opposition with data (e.g., commissioned polls, “expert” legal studies, etc.).
• Critics also contend that Iceland has only a nascent tradition of debating the social impact of biotechnology and the implications of the Human Genome Project (see Wagenmann 1999).
• Critics charge that the Parliamentary Committee on Health and Social Insurance played a crucial role in pushing the bill through parliament.

Is the Controversy Over?

• Critics charge that broad community support for the database does not exist and that controversy is still fierce (see Sigurdsson, “The Databank Takeover of Iceland,” May 13, 1999. This article will appear in a slightly abridged form as “Icelandic Genes,” in Committee on Intellectual Correspondence Newsletter, Summer 1999.)
• Critics charge that the “independent legislature” of Iceland is not so “independent” when one considers that DG brought $200 million in foreign investment into a national largely dependent on fishing.

deCODE’s Response

• DG surveys other centralized healthcare databases in Denmark, Sweden, New Zealand, and the U.S., claiming that its Icelandic database does not present significantly different privacy issues (see http://www.decode.is/islenskerfdagr…sroom/articles/other_databases.html).
• DG announced in May of 1999 that it will establish an independent Ethical Advisory Board to ensure that the company applies the highest ethical standards in its research.

Genome Technology & Reproduction

• Values & Public Policy, A Community Dialogue Project (Michigan)
• Initiated in 1997
• Funded by NIH – ELSI Program (Ethical, Legal, & Social Implications of the Human Genome Project)
• Sponsored by:
• Professor Leonard Fleck, Center for Ethics & Humanities in the Life Sciences, Michigan State University (East Lansing); and
• Professor Toby Citrin, JD, School of Public Health, University of Michigan

Michigan Community Dialogue Project Summary

• 3-year project to develop ethically grounded policy, professional and institutional standards
• Project identifies values, attitudes and beliefs that citizens, patients and practitioners hold toward genetic technology.
• Project develops recommendations for public policy and reproductive options based on insights gained through a series of group processes.

Community Dialogue Project Mission

• To test a model for more informed public discussion about controversial public policy issues intended to move beyond political slogans and sound bites.
• To examine through “rational democratic deliberation” how the use of genetic knowledge and genetic technology should be guided by society to assure its appropriate role as a tool to alleviate suffering and prevent illness, while avoiding its potentially harmful effetcs on communities and individuals.
• To begin to determine through community dialogue what social or public values in a democratic, pluralistic, tolerant society may legitimately constrain the zone of individual reproductive privacy and reproductive liberty through professional or institutional policy.
• To frame policy options regarding genetics and reproductive choice that are most congruent with those individuals and social values that democratic consensus endorses as most worthy of protection.

Project Format

• The project combines several forms of group process to address the difficulties that arise when issues of high technical and scientific complexity merge with issues involving emotionally charged ethical, moral and religious views:
• Focus Groups
• Community Dialogues
• Policy Conference
• Dissemination

Focus Groups Phase

• 9 lay groups convened in 1996
• 2 professional groups convened in 1997
• project collected information from different segments of the population
• project identified value conflicts/concerns expressed by participants regarding advances in genetics and their impact on reproductive decision-making
• project identified concerns to serve as the raw data for the community dialogue phase of the project

Community Dialogue Phase

• 50 community participants selected per site
• 7 sites (Detroit, Ann Arbor, Lansing, Saginaw/Bay City, Kalamazoo, Grand Rapids, Holland)
• Project included two “chunks”
  Fall 1996 (moral Issues)
  Spring 1997 (policy issues)
• Each “chunk” included in 6 two-hour evening sessions at weekly intervals

Background Preparation

• Participants complete background reading before each session
• Session preceptors (philosophers medical ethicists) link readings to hypothetical moral/policy scenarios
• During the sessions participants use interactive keyboards to record their responses on a 1-5 scale; interactive graphs are created for each question
• 30-50 people in each community take part in the sessions

Background Work

• participants represent a wide spectrum of ages, work backgrounds, socioeconomic status, health status, and racial and ethic backgrounds
• participants with strong positions were consciously selected by researchers – two Catholic priests, “Right-to-Lifers,” and disabled persons were included among participants

Participants’ Roles

• To determine the moral and social values at stake in public policy issues raised by advances in genetics that have a bearing on reproductive decision-making
• To judge whether genetics and reproduction are matters of reproductive liberty and private choice that should be beyond public and professional regulation and control
• To decide whether important social values should justifiably constrain some of these personal choices
• To determine the extent to which we have, or could create, sufficient social consensus through rational democratic dialogue to shape feasible and fair social policies balancing these differing value perspectives

Unexpected Spin-Offs

• At the conclusion of his participation in the project, one retired physician created spin-off project by acting as the preceptor for a group of senior citizens
• The seniors met for a series of 5 two-hour discussions

Policy Phase

• Policy conference was held on March 17, 1997
• 75 participants, including representatives from the state legislature, the community health department, professional societies, health insurance organizations, and the 7 cities involved in the community dialogue
• Purpose of the conference was to link community dialogue participants with policy-makers
• Proceedings from the conference are available to the public

Timetable

• Thorough review of existing and proposed legislation and analogous laws related to genetics issues (Summer 1997)
• Draft 1 of Policy Approaches/Recommendations (January 1998)
• Draft circulated to dialogue participants
• Groups reconvened to modify report (February/March 1998)
• Policy Approaches / Recommendations Report (May 1998)

Recommendations

• Project investigators generated recommendations for governmental policies, professional standards, and institutional guidelines that reflect values expressed by the communities in Michigan.
• This set of recommended policy approaches and professional/institutional standards serves as a guide to the introduction and utilization of new genetic technologies related to reproductive decision-making
• Project investigators hope that these policies/standards may serve as a model for others state and national groups.

Dissemination Phase

• National conference, “Genome Horizons: Public Deliberations & Policy Pathways,” was held in Washington, D.C. on May 15-16, 1998
• Findings and recommendations shared with:
  Legislators and legislative staff (state/federal)
  Leaders of professional organizations responsible for setting standards of practice
  Leaders of the health care providers and insurance organizations
• Policy strategies regarding the genetic privacy, access and financing, and the new reproductive technologies were discussed
• Articles in journals and publications targeting policy-makers
• Conference Proceedings distributed to participants/policy-makers

Some Findings: Moral Judgments from Fall Dialogues (60-70%)

• Genetic Privacy: There ought to be a strong presumption in favor of protecting the genetic privacy of individuals. Individuals should have a presumptive right to protect genetic information about themselves from disclosure to others.
• Genetic Responsibility: Any individual’s right to privacy should be limited when it adversely affects the equally important rights or interests of others. More strongly, there is some range of genetic facts about ourselves that we are morally obligated to reveal to potential spouses, sometimes to siblings, generally not to employers/insurers.
• Genetic Responsibility: Though I might have a strong right not to know certain genetic facts about myself (because it might prove to be too painful and self-destructive), I may not be morally justified in exercising that right if the serious welfare interests of future children are put at risk. [The point here pertains to serious medical problems children might be vulnerable to from early on in life as a result of their genetic inheritance. There is less certainty about this judgment if the genetic disorders we have in mind are connected to mid-life susceptibility genes, such as for breast cancer or Huntington’s or Alzheimer’s.]
• Genetic Privacy: The genetic privacy of children ought to be respected when there are no therapeutic goals to be achieved by parents having that genetic information.
• Genetic Liberty: Individuals who are going to marry and who intend to have children are not morally obligated to undergo a battery of genetic tests to define their genetic endowment and to identify any genetic risks they might pose to their possible children.
  Comment: This statement is not entirely congruent with the earlier statements about genetic responsibility that seemed to be strongly endorsed. This might have to do with the implied breadth of genetic testing suggested by the item. That is, there is only a limited range of genetic conditions that individuals would be morally obligated to be knowledgeable about regarding their own genetic endowment and its implications for future children they might have.
• Procreative Liberty: Parents should be morally free to pursue whatever alternate reproductive technologies are available to avoid the birth of a child with a serious genetic disorder. [The implication of this judgment is that such technologies are not intrinsically morally flawed; and hence, accessing them for this purpose is a morally permissible option.]
• Note: There was 65% support among respondents in general (though there was considerable variation across communities) for the idea that couples ought to have the right to access pre-implantation genetic diagnosis and IVF in order to avoid the birth of a child with cystic fibrosis. This technology requires the creation of multiple 8-cell embryos, some of which will be discarded. This seems to have been the source of much moral disagreement on this item.
• Genetic Discrimination: There was 65% rejection among respondents of the notion that preimplantation genetic diagnosis represents a form of invidious discrimination against individuals with disabilities, though there was considerable variation across communities.
• Social Genetic Responsibility / Social Justice: General rejection of the notion that society ought to subsidize access to alternate reproductive technologies for individuals who wanted to use them to avoid the birth of a child with a serious genetic disorder that would adversely affect the length of life or quality of life of that child. The subsidy suggested in the question was 50% of the costs. About 20-25% of the respondents thought there ought to be such a society subsidy.

Some Policy Conclusion from Spring Dialogues 

• Legal mandates for any kind of genetic testing are generally strongly resisted, even when the welfare of future children is at risk.
• Legally mandated, pre-marital genetic counseling is acceptable to about half the dialogue participants as a mechanism for assuring social genetic responsibility
• There is broad acceptance of the political legitimacy of government protecting the genetic health of future children [70-75% level], but legal mandates generally do not seem to be an acceptable means to that end.
• Government-mandated educational approaches to encouraging and motivating more responsible genetic choices by individuals is endorsed at 75-80%. If that educated approach is targeted through the school system, that level of support drops to the 55-60% range.
• Government-provided economic incentives for genetic counseling and genetic testing to get more responsible genetic decisions are endorsed at the 50-55% level. Opposition to such support was in the 30-35% range.
• Significant concern and uncertainty about structuring economic incentives for genetic counseling/testing through health plans attached to employers, perhaps for fear of adverse consequences on employment/loss of privacy.
• Virtually even division of judgments on whether professionals should counsel more directively to elicit responsible genetic decisions, as when the rights/interests of potential children/spouses are at risk.
• Strong opposition [75%+] to any social policies that would mandate genetic testing of couples who were clearly at risk on the basis of family history of having a child with a serious genetic disorder that would affect them from early on in life; opposition increases still more if the genetic disorder occurs only late in life.
• Virtual even split in judgment that we should have laws mandating insurance companies to pay for IVF when intent is to avoid conceiving a child with a serious genetic disorder. Similar support for funding IVF with preimplantation genetic diagnosis/embryo selection drops to 23%.
• Strong opposition [85%] to any legal mandate to have children via IVF to avoid conceiving a child with a serious genetic disorder.
• Almost equally strong opposition [75%+] to any legal ban on access to preimplantation genetic diagnosis, or other alternative reproductive options.
• Strong opposition [70%+] to the idea that preimplantation genetic diagnosis represents invidious discrimination against the disabled worthy of a legal ban.
• Strong opposition [70%] to permitting religious beliefs that full personhood begins at conception to shape public policy.
• Strong support [80%] for the idea that maximizing individual procreative liberty is politically the most legitimate way to allow religious values to shape individual reproductive decisions.
• Fairly strong support [60%] for government regulation of dissemination of genetic tests to protect consumers; but even stronger support [80%] for professionals doing just that.
• Very strong opposition [86%] to laws requiring revelation of genetic information to relatives who might make different reproductive choices with that information; but very strong support [75%] for health professionals in counseling roles to strongly and directly counsel such revelation.
• Strong support [75%] for federal mandates for genetic counseling and education to accompany genetic testing; even strong support [90%] for health professionals having this as professional policy.
• A strong majority [65% vs. 20%] is opposed to any laws that would ban the development of the capacity for germline genetic engineering.
• If we are successful in developing germline genetic engineering, then there is almost an even split regarding the idea that counselors should take a more directive approach with individuals whose children would be at risk of being born with a serious genetic disorder.
• Strong support [70-80%] for federal laws that would ban insurance companies from using genetic information to price health insurance or to deny it altogether to an individual.
• Very strong support [90%] for federal laws banning employers from collecting genetic information.
• Significant support [37%] for a federal law that would ban prenatal testing for late onset adult disorders [HD / AD] when intent of the parents is abortion; 53% were opposed to any such policy.

Reports on the Project

• Two “Genome Technology & Reproduction: Values & Public Policy” reports were compiled for Fall 1996 and Spring 1997.
• These reports on the project are available from Professor L. Fleck, Michigan State University, fleck@msu.edu.

Conclusion: What Makes for Ethical Decision-Making?

• Social Justice: panel participants should be selected using methods that insure racial, class, gender and ethnic diversity
• Distributive Justice: discussions should consider who benefits from, and who has access to, new medications and technologies

Conclusion: What Makes for Democratic Decision-Making?

• Dialogues: Education + Discussion
• Interaction: Expert Input + Community Discussion + Expert Response + Community Formation of Policy Recommendations
• Listening: concerned segments of the population need to be heard
• Spin-offs: “domino” discussions should be encouraged
• Collaboration: biotech companies need to be engaged early in public consensus formation