tag:blogger.com,1999:blog-37148773.post7087625057287631459..comments2024-03-18T09:58:09.828-04:00Comments on <center>Sandwalk</center>: The Ethics of Genome AnalysisLarry Moranhttp://www.blogger.com/profile/05756598746605455848noreply@blogger.comBlogger9125tag:blogger.com,1999:blog-37148773.post-54585642049867842602012-08-28T13:39:36.034-04:002012-08-28T13:39:36.034-04:00How do you decide which information is "clini...<i>How do you decide which information is "clinically relevant"?</i><br />We have a clinical bioethics review board and they get to make all of these tricky judgement calls. The board is composed of, exactly as you suggest, physicians, philosophers (specializing in bioethics) and scientists. The possibility of detecting non-paternity is also explicitly written into the consent form.<br /><br /><i>As long as the patients know that the sequence of their genome can easily be traced back to them by anyone on the research team, then there's no ethical problem. </i><br />This is not the case. In fully-identified studies there is a database that links coded study numbers to patient identifiers. The database is encrypted with generally only one or two specific individuals with the access key. In non-identified studies, there is no such database and no one can trace patient samples back to individuals.<br /><br />Note that in the United States (where this research is conducted) HIPAA regulations protecting patient privacy are very strict, with significant penalties associated with unauthorized disclosure. The list of HIPAA protected health identifiers (PHI) is:<br />1) Names<br />2) Geographic subdivisions smaller than a State<br />3) Dates (except year) directly related to patient<br />4) Telephone numbers<br />5) Fax numbers<br />6) E-mail addresses<br />7) Social security numbers<br />8) Medical record numbers<br />9) Health plan beneficiary numbers<br />10) Account numbers<br />11) Certificate/license numbers<br />12) Vehicle identifiers and serial numbers<br />13) Device identifiers and serial numbers<br />14) Web URLs<br />15) Internet Protocol (IP) address numbers<br />16) Biometric identifiers, including finger and voice prints<br />17) Full face photographic images and any comparable images<br />18) Any other unique identifying number, characteristic, or code, except as permitted under HIPAA to re-identify data<br /><br />Clinical/Translational research is not trivial to do correctly. There should be an office at your institution to help researchers navigate the requirements and regulations successfully.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-37148773.post-4202607954763139592012-08-28T09:50:22.656-04:002012-08-28T09:50:22.656-04:00Like you, I tend to make a distinction between &qu...Like you, I tend to make a distinction between "ethics" and "morals." In my case, "morals" is a null set—there's no such thing in my worldview.Larry Moranhttps://www.blogger.com/profile/05756598746605455848noreply@blogger.comtag:blogger.com,1999:blog-37148773.post-53513737735527416452012-08-28T09:46:40.921-04:002012-08-28T09:46:40.921-04:00You are free to conduct your research in this mann...You are free to conduct your research in this manner if you choose.<br /><br />As long as the patients know that the sequence of their genome can easily be traced back to them by anyone on the research team, then there's no ethical problem. <br /><br />How do you decide which information is "clinically relevant"? Is it clinically relevant to let a patient know that she should have no fear of inheriting something from her father because that's not her father? Is it clinically relevant to inform a patient that they have a 10% higher risk of getting Alzheimer's when they are 80 years old? <br /><br />Do you have experts on your research team (physicians , philosophers, scientists) who have drawn up a list of alleles that pass the "clinically relevant" threshold? Can you share that list with us?<br />Larry Moranhttps://www.blogger.com/profile/05756598746605455848noreply@blogger.comtag:blogger.com,1999:blog-37148773.post-59101958269721437222012-08-28T08:08:41.485-04:002012-08-28T08:08:41.485-04:00The ethical thing may or may not be the correct mo...The ethical thing may or may not be the correct moral thing. All ethical rules are heuristics, subject to stronger moral demands from other obligations. This case is interesting because the competition is between 2 high priority morality values.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-37148773.post-5785055565242833332012-08-27T16:43:16.502-04:002012-08-27T16:43:16.502-04:00This is not as simple as you make it out to be, si...This is not as simple as you make it out to be, since there are potential people involved other than the research subjects and the researcher. For example, suppose the researchers discover the patient is HIV+? Better consent forms will help. In studies I coordinated, the consent form explicitly states something along the line of, "although we are not directly looking for clinically relevant information in this study, if a result of potential clinical relevance is found, you will be informed".<br /><br />In many cases (such as above) the study is carried out with fully-identified individuals, for example, in order to correlate molecular analysis with future clinical outcomes. The people on the bench doing the technical work only know sample codes, but there is an individual that can match those codes back to patient identity. Almost all double blind experiments are eventually unblinded so the results can be interpreted.Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-37148773.post-51316704624271351332012-08-27T16:20:04.307-04:002012-08-27T16:20:04.307-04:00The researchers should not know what the patient p...The researchers should not know what the patient plans to do.<br /><br />They should also know that they have no right to contact the patient. There should be a strong barrier of protection around the identity of the subjects. We have plenty of experience with double blind experiments. We know how to do this. Larry Moranhttps://www.blogger.com/profile/05756598746605455848noreply@blogger.comtag:blogger.com,1999:blog-37148773.post-7298582769547039002012-08-27T16:16:53.258-04:002012-08-27T16:16:53.258-04:00If the subject of the course is really human biolo...If the subject of the course is really human biology then I can think of dozens of important concepts and principles that have to be covered. None of them require knowledge about the "limits of research." <br /><br />We spend a good deal of time in one of my courses talking about ethics—what it is and why it is sometimes relevant and sometimes not. I've always had the advantage of teaching with someone who has substantial training in philosophy. This comes on very handy during class discussions when we inevitably end up talking about different opinions on ethical questions. <br /><br />It's hard to get students to think critically about these issues because they come into class loaded with all kinds of misconceptions about ethics. They often can't tell the difference between a scientific controversy and an ethical problem.<br /> Larry Moranhttps://www.blogger.com/profile/05756598746605455848noreply@blogger.comtag:blogger.com,1999:blog-37148773.post-29050179406189025882012-08-27T13:52:00.482-04:002012-08-27T13:52:00.482-04:00Furthermore, it should be impossible for them to f...<i>Furthermore, it should be impossible for them to find out the name and address of the donor so the issue should never come up.</i><br /><br />Hang on, there's no evidence that the researchers knew this. The only information they had at the time was:<br /><br />1) The patient comes from a family with a segregating high-risk allele<br /><br />2) The patient does not bear the high-risk allele<br /><br />3) The patient intends to have a prophylactic double mastectomy.<br /><br />None of those factors violate ethical gudelines, in fact (1) and (2) are inherent in the fact that it was a mapping study. One can argue that the researchers shouldn't have known point (3) - it really depends on whether it was necessary for the study. Or maybe their entire study sample was people planning to have a mastectomy, we just don't know.<br /><br />On the basis of (1) to (3), they approached their ethics board for guidance. Clearly you feel that the ethics board should have made a different decision. I don't however think the researchers were wrong to check. Peterhttps://www.blogger.com/profile/12559721137290332762noreply@blogger.comtag:blogger.com,1999:blog-37148773.post-33597119308598293342012-08-27T13:44:12.154-04:002012-08-27T13:44:12.154-04:00Teaching students about human biology means teachi...Teaching students about human biology means teaching them about the limits of research, many of which are ethical limits. <br /><br />For my undergraduate students, they are far more likely someday to consider participating in research than to become researchers themselves. They should understand that participating in most research studies will not provide them any direct benefit, even if researchers may find something that would be directly relevant to their health decisions. As citizens, they should consider whether why researchers are regulated in this way and whether they support greater or less regulation of researchers. <br /><br />John Hawkshttps://www.blogger.com/profile/17027862713126904206noreply@blogger.com