HGP and Biobanks - Social, Legal, Ethical Issues Flashcards
How is broad consent different from informed consent?
A participant gives consent to have their samples used for all research projects when they submit their samples. Informed consent requires that the participant consents to each research project after they are told all the risks and benefits
Why is informed consent difficult for biobanks?
No one really knows what the risks are, if genetic privacy is a concern, can’t guarantee that genetic discrimination won’t occur
What are the logistics reasons that biobanks often use broad consent instead of traditional informed consent?
The research projects that use data from biobanks are huge and require huge sample sizes. It is very difficult and expensive to contact everyone for consent for each research project
What are the ethical challenges to why it is difficult to use informed consent for biobanks?
It isn’t clear how the information will be used and what might come out of it, hard to have an exhaustive description, can’t predict all risks and benefits, or 100% guarantee privacy
Why might there be implications for relatives if someone puts their DNA into a biobank?
You share 50% of your DNA with your siblings and parents, so to an extent their DNA also ends up in the biobank
Are relatives required to consent before someone shares their genetic information?
No
Are you required to disclose information to relatives if a high-risk allele is identified?
No
Historically who owns the tissue sample in a biobank?
Belongs to whoever did the biopsy once it was no longer on you
How can restrictions on research be both harmful and beneficial?
Harmful because limiting research reduces the public good of the research, but beneficial when it allows for more individual rights
When were the earliest patents of human genetic information?
1982
Why was the court case against Myriad genetics in the US a landmark case?
Determined whether human genes and alleles were patentable
Why was Myriad genetics challenged in court?
They “owned” the BRCA1/2 genes and marketed an absurdly expensive test for those alleles. Since they owned the gene, they had a monopoly on the tests for those genes and nobody was allowed to do any other sort of test
What was the court ruling in the Myriad genetics case?
Human genes are natural material so they can’t be patented since they aren’t an invention
Have there been any landmark cases like with Myriad genetics in Canada?
No, we don’t know if patents would be upheld in court
Does Canada have any specific laws about patenting human genes? Have any patents been issued?
No, but patents have been issued
