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Record W158790181

Legal and ethical issues in ART "outcomes" research.

2005· article· en· W158790181 on OpenAlexaffabout
Erin Nelson

Bibliographic record

VenuePubMed · 2005
Typearticle
Languageen
FieldMedicine
TopicReproductive Health and Technologies
Canadian institutionsLawson Health Research Institute
Fundersnot available
KeywordsThe artsContext (archaeology)Reproductive technologyDiversity (politics)Assisted reproductive technologyBioethicsMedicinePsychologyPolitical scienceLawPregnancyGeography
DOInot available

Abstract

fetched live from OpenAlex

I. Introduction Assisted reproductive technologies (ARTs) have become almost commonplace in the developed world. It is estimated that 1% of American children are now conceived using some form of assisted reproduction, (1) and that over a million children have been born as a result of the use of ARTs (2) In the past several years, however, scientists have begun to sound a cautionary note about the health outcomes of ARTs, as it appears that children conceived using ARTs may be at higher risk of birth defects and certain genetic anomalies than those conceived naturally. As a result of these new findings, a consensus appears to be emerging that research into the safety of assisted reproductive technologies (ARTs) is required. Such research will require a longitudinal, prospective design in order to answer questions about short and long-term health outcomes for those conceived using ARTs. There are a number of scientific issues that require attention before ART outcomes research can be successfully conducted; these include: sample size limitations, the diversity of both types of ARTs and birth defects, and confounding variables such as maternal age and folic acid consumption. (3) But a substantial non-scientific impediment to the conduct of this research also demands consideration: legal and ethical constraints that have the potential to complicate the research enterprise. In particular, given the research context, law and policy relating to the research participation of pregnant women and children must be attended to. The question of whether and to what extent pregnant women and children may participate in health research has been a persistent concern in both legal and ethical circles. (4) On the one hand, current ethical guidelines exhort researchers to include these populations where possible; (5) on the other, the law seems to pose a barrier to their participation. In this article, the intent of which is to raise issues requiring further consideration, I will examine legal and ethical standards relating to consent in the Canadian context, and highlight the legal and ethical concerns that arise at different stages of longitudinal prospective research studies in the ART context. In Part II, I explain the ART context and highlight the concerns that have led to calls for long-term follow-up of children conceived using ARTs. In Part III, I discuss consent to research participation along the continuum of participants in longitudinal ART outcomes research, and in Part IV, I move on to consider legal and ethical regulation of health research generally. I conclude by noting that the legal and ethical parameters around consent to longitudinal ART research must be clarified in order to permit rather than hinder the conduct of this important research. II. The Context: Assisted Reproductive Technologies In the almost 30 years since the birth of the first test-tube baby, (6) the science around reproductive and genetic technologies has exploded, giving rise to new tests and technological breakthroughs on a routine basis. Preimplantation genetic diagnosis (PGD), for example, permits scientists to diagnose genetic conditions in an in vitro embryo, (7) prior to it being implanted in a woman's uterus through in vitro fertilization (IVF), a technology in which an ovum is fertilized with a sperm cell outside the woman's body. (8) And if IVF alone will not suffice to assist a couple to conceive, because of very low sperm count or immotile sperm, a procedure termed intra-cytoplasmic sperm injection (ICSI) might be appropriate--a single sperm cell can be injected directly into the ovum to ensure that fertilization takes place. (9) Other variations on the IVF theme include a procedure called in vitro maturation (or IVM), in which immature oocytes are matured in vitro for 24-48 hours, eliminating the need for risky hormonal stimulation of the ovaries prior to harvesting eggs, (10) and IVF with blastocyst embryo transfer, which involves waiting for five to six days post-fertilization to transfer the embryo(s) to the woman's uterus, which, it is hoped, will lead to a greater likelihood of implantation. …

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.002
metaresearch head score (Gemma)0.003
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.602
Threshold uncertainty score0.423

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0020.003
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.001
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.103
GPT teacher head0.424
Teacher spread0.320 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations3
Published2005
Admission routes2
Has abstractyes

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