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PubMed · 15997529

Guidelines: egg donation and consent forms.

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Abstract

Egg donation has caused the Interim Licensing Authority concern in the last year. In its latest annual report it has issued additional guidelines on the subject. It has also issued a booklet 'Egg Donation: your questions answered' to be given to all prospective egg donors. The booklet contains a consent form for egg donation. The new guidelines and consent form are reproduced below. Also reproduced is the standard ILA consent form for in vitro fertilisation, which all licensed IVF units must use.

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Consent FormsCounselingFemaleFertilization in VitroGuidelines as TopicHumansInformed ConsentOocyte DonationUnited KingdomGenetics and ReproductionInterim Licensing AuthorityJournal Article

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1990. Guidelines: egg donation and consent forms.. https://pubmed.ncbi.nlm.nih.gov/15997529/

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PubMed2006

Randomized consent designs in randomized controlled trials: systematic literature search.

BACKGROUND: Three types of randomized consent designs are distinguished and ranked according to the extent to which participants are informed about treatment options: single-consent (those in the experimental group learn about their assigned treatment), incomplete-double-consent (all participants learn about their assigned treatment), and complete-double-consent (all participants learn about all treatments studied). All are methodologically, ethically, and judicially controversial. Even so, their use is justified if blinding is deemed necessary, but impossible to achieve by sham procedures (placebo), and experimental treatment seems attractive to potential participants. OBJECTIVE: The aim of this study is to give a comprehensive overview of the use of randomized consent designs. Data sources are MEDLINE (1/1977-2/2003), EMBASE (1/1984-2/2003), PsycINFO (1/1996-2/2003), the Cochrane Library, and the Science Citation Index database. REVIEW METHODS: Eligible were studies using a randomized consent design. Cluster randomized trials were excluded. One reviewer selected and data-extracted eligible papers. A second reviewer independently data-extracted 10% of the papers. Data on country of study conduct, year of commencement, area of medicine, type of design, reason(s) for use, details on approval by a research ethics committee, the index and reference intervention, nature of endpoints, and details on collection of data were extracted. Furthermore, for each trial, the rates of non-compliance and loss to follow-up were registered by treatment arm. The three types of randomized consent designs were compared as to differences between the rates of non-compliance and loss to follow-up in the separate trial arms. RESULTS: Randomized consent designs are seldom used (n=50). When used, they have often been used in the wrong circumstances (misuse). In 65% of the studies the non-compliance in the index group is larger than in the reference group. Contrary to expectation, trials using the incomplete-double design were associated with significantly higher rates of non-compliance and loss to follow-up in the reference groups than trials employing the other two versions. CONCLUSION: Trialists and physicians should be aware of the proper indication for the use of randomized consent designs.

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