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Bartha Maria Knoppers

Publications and source records attributed to Bartha Maria Knoppers.

13 recordsLinked to original sources
PubMed2025

Toward ethical provenance tracking: The GA4GH model data access agreement (DAA).

PURPOSE: Standardizing contractual clauses that govern data access enables research institutions to responsibly steward genomic and related health data while enabling its efficient downstream reuse. METHODS: We describe a document analysis study using both qualitative and comparative law analytical approaches to identify the most common categories of clauses from 29 different data access agreements used by human biomedical research consortia globally. We furthermore characterized the legal positions and standard practices for each common element of the agreement and synthesized across them to develop model clauses. A total of 3 discussion sessions were organized virtually to refine the clauses among members of the Ethical Provenance Subgroup of the Global Alliance for Genomics and Health. RESULTS: We developed 15 unique data access clauses corresponding to the most common legal elements identified in the sampled agreements. CONCLUSION: Model clauses can be used to drive administrative efficiencies and institutional compliance for managing access to human genomic data for research. Additional machine-readable consents and software solutions are needed to support traceable "ethical provenance" of human genomic data and communicate data use conditions throughout the data's life-cycle.

Humans↗
PubMed2002

Serious genetic disorders: can or should they be defined?

The word "serious" appears in laws and policies regarding genetics services but is not defined. Genetics professionals would most likely be consulted if definitions are made. We surveyed all U.S. board-certified genetics services providers and all members of the European Society of Human Genetics (ESHG), Canadian College of Medical Geneticists (CCMG), and Ibero-American Society of Human Genetics (IASHG), using anonymous, mailed questionnaires. Respondents were asked to list three conditions they considered lethal, three that were serious but not lethal, and three that were not serious. Of 3,317 asked to respond, 1,481 (45%) returned questionnaires. Analysis was limited to responses of the 1,264 (85%) who saw patients. Respondents listed 537 conditions, with extensive overlap between categories; 46% of conditions listed as serious were also listed as not serious and 41% were listed as lethal. Respondents did not want professional societies, laws, or national ethics committees to define serious. They favored individual patients as decision makers, with the help of individual doctors. Their reasons were that genetic disorders vary in expression, individuals perceive disorders differently, professional or legal definitions could be unfair to minority groups, definitions tend to be inflexible when new treatments appear. In the United States, most would not use a definition of serious to limit reproductive services, carrier screening, or neonatal intensive care; outside the United States, more supported limitations. There is not sufficient consensus among experienced genetics professionals to define serious genetic conditions for purposes of law or policy. Responses point to social and economic influences on perceptions of what constitutes a serious genetic disorder.

Female↗
PubMed2002

Genetic information and the family: are we our brother's keeper?

Nowhere are the principles of autonomy and privacy more frequently underscored than in the context of modern human genetics. Fear of untoward socioeconomic and psychosocial consequences of genetic knowledge has reinforced the need for medical confidentiality. However, genetic information is necessarily familial and the needs and interests of other family members cannot be ignored. The past decade has witnessed a gradual move away from the status quo position of absolute confidentiality, to an intermediary position of it being the duty of the patient, to a position making it ethically permissible for the physician to warn in certain limited circumstances. Founded on the principle of mutuality, this last position will revolutionize not only the physician-patient relationship but also the modern, nuclear family.

Confidentiality↗
PubMed2002

Science and society: children and incompetent adults in genetic research: consent and safeguards.

Recent changes to the legal and ethical criteria that govern the inclusion of children and incompetent adults in genetic research are likely to lead to advances in research, but might leave the rights of the participants in this research in need of additional safeguards. Here, we discuss why this might be and propose policy considerations that could help to protect the rights of these particularly vulnerable groups of research participants.

Adolescent↗
PubMed1993

Reproductive genetics: Canadian and European perspectives.

Unlike medically assisted conception, the issue of the impact on women of reproductive genetic testing has been characterized by the emergence of a more 'relativist' position. This relativist position is grounded in the understanding of the universality of problems arising from human genetics. An analysis of the major reports emanating from different European countries will demonstrate that the discussion regarding the impact of medically assisted conception and reproductive genetic testing on women is often incidental and secondary. There are similarities and differences in the issues raised in the evaluation of both these technologies. Similarities, in their experimental character, the concomitant social pressure, the myth of the perfect child and the increased medicalization. Differences, in the inherent responsibility or guilt accompanying genetic testing, the timing of choices, the possibility of sex selection, the use and control of genetic information, the sense of intergenerational responsibility and the current qualification of such genetic testing as medical and diagnostic as opposed to a technology of 'convenience' as was often the case with the treatment of infertility. In contrast to the European reports, the work of the Canadian Royal Commission on New Reproductive Technologies has as its primary focus the impact of both these technologies on women, children and society.

Abortion, Eugenic↗
PubMed1992

Rationale for an integrated approach to genetic epidemiology.

CONCLUSION: Genetic knowledge is now in the public domain and its interpretation by the media and the citizens brings the issues into the public forum of discussion for the necessary ethical, legal and socio-cultural evaluation of its application. Science is being perceived by some as dangerous and as requiring international regulation. Others feel that genetic knowledge will be the breakthrough that will permit medical progress and individual autonomy with regards to personal health and lifestyle choices. The mapping of the human genome has already yielded valuable information on an increasing number of diseases and their variants. Prevailing popular and journalistic archetypes ("imaginaires") used in the media are perceived by the producers as slowing down the possible application of genetic knowledge. The answers to these dilemmas are not readily apparent nor are they prescribed by classical philosophy of medicine. Since genetic knowledge eventually resides with the individual who carries the genes of disease and/or susceptibility, a logical approach to integration of this knowledge at a societal level would seem to reside with individual education and decision-making. The politics of the ensuing social debate could transform the current social contract since an individual's interests need to be balanced against those of his or her immediate family in the sharing of information. The ethical foundations of such a contract requires the genetic education of "Everyone" as a matter of urgent priority. Genetic education should not serve ideological power struggles between the medical establishment and the ethical-legal alliance. Instead, it should ensure the transfer of knowledge to physicians, to patients, to users, to planners, to social science and humanities researchers and to politicians, so that they may make "informed" and free decisions....

Base Sequence↗
PubMedDate not supplied

Newborn genetic screening: ethical and social considerations for the nineties.

As we head into the next decade, the impact of the use of genetic screening programs for immunological surveillance purposes (such as for HIV) and for possible DNA typing should not be underestimated. The authors present ten principles which seek to reaffirm the basic tenents of neonatal screening programs -- the benefit of newborns. These principles are both protective and yet open to the complex ethical and social considerations raised by such new uses of newborn genetic screening programs.

Coercion↗