Experts answer bioethics questions from the public

Sorensen asks for questions from the general public, and the first is from a CityClub charter member, Maryel Duzan. She asks about “the white coat problem” — described generally as biases and problems introduced by personal interaction with a doctor or scientist. Examples of the problem cited by Duzan are that some people don’t remember what they’ve been told, or feel personally compelled toward consent by this interaction.

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Duzan’s question, then is: As a potential solution to the white coat problem, has anyone considered using videos to establish understanding and consent in place of a one on one interaction?

Sewards notes that “We think of consent as an on-going process.” That is, they ensure participants have an on-going understanding and that forms stay updated.

Russell, for GAPPS describes that their study coordinators know the women across a long period of time, so there are a lot of questions back and forth.

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For GAPPS donors then, there is a lot of time to think about consent.

Edwards adds there are new consent forms with more options, with which you can opt into or out of different parts of the research.

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Still better, some of Edwards’ bioinformatics colleagues are working on a software interface with a question and answer experience on a computer. This is to lead you through the choices and help identify what you really want in terms of consent.

Next, writer Sally James from the Northwest Science Writers Association (@jamesian on Twitter) begins: “I find the definition of ‘informed’ to be really tricky right now. For those of us familiar with proteomics (the large-scale study of proteins, particularly their structures and functions) we can imagine: can anyone right now know the ramification of giving a DNA sample?

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We are on the cusp of learning so much more information, and things are changing so quickly, James summarizes: “Can anyone know what we’re consenting to?”

Edwards replies: “This is exactly why I wonder whether we’ve out grown the usefulness of classic consent. I think we’ve outrun the term ‘informed consent’. We don’t know all the risks and benefits with respect to genetic information. We’ve had a number of conferences with experts in the room … and we still cannot anticipate all the risks.”

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Edwards continues: “We should shift to consenting to a process … [such as] I agree to be a part of this bank, I understand there is a governing process, and if things change you will contact me again,” rather than committing to everything in the future at this one time.

Renee Delong, Regulatory Affairs Project Coordinator at Fred Hutchinson Cancer Research Center asked “What steps do you recommend to build public trust around biorepositories?”

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Delong added, “I believe in the promise of biorepositories,” while mentioning a recent New York Times article about use of the Internet as a sort of repository for patients with rare genetic disorders. These patients openly share symptoms and diaries online which researchers can then, also access.

Edwards replied that communication and being transparent, having accountability, and having systems in place to know where the data are are all essential to building trust. She also stressed that biobank experts don’t yet know all the answers and they are open to suggestions.

Edwards agreed that people are absolutely owed some results back, but noted that not everyone wants to known their own personal results. Many people just want to know how the research is going in general. Individual results may not be conclusive or relevant, but scientists can give back more in terms of general results.

To another question from Delong, Russell replies that GAPPS participant-donors can change their minds up until that specimen has been sent out for research. Samples left behind or not yet used can be destroyed, and donors can be given confirmation that it’s been done.

Sewards adds: Every consent form has the phone number of the reviewing IRB, and they would love to hear from more people! — http://www.washington.edu/research/hsd/

Wendy, a member of CityClub and not a scientist says: “I would donate blood for science. What is the parade of horribles?” i.e. what are people’s objections to doing the same? She continues, “I don’t understand what all the issues are. If data are anonymous what are people worried about?”

Sewards outlines: “We are concerned if someone’s genetic information is out there without enough safeguards. Say an employer or someone else may find data related to health test results, like a test for HIV, and that data could come back to hurt you.”

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Sewards particularly notes again that right now, DNA is seen as only identifiable with related and associated information, but what about five years from now?

Edwards adds: If you are a part of a clearly identifiable community such as by your ethnicity, there is also concern about research which could stigmatize your community. An example: whether a particular ethnicity is more inclined to commit crime. Perhaps you gave your blood to fight disease and it ends up being used in unintended ways, which are not personally, but socially disagreeable to you.

Ryan Luce, co-founder of Corengi asked whether there is a public health consideration which answers the privacy concerns of individuals.

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Edwards replied that some patient groups, especially want more data shared and publicly. Open data and more open access to data and research might bypass even institutions themselves. Some want the data available to anyone who might use it and make a breakthrough.

Russell noted that many of the women in GAPPS have no problem with data sharing but that GAPPS still feels the responsibility of that trust being placed in them. “We don’t want people to ever feel bad about what they did.”

Sorensen, our moderator offers one closing question: “We have an enormous opportunity to move research forward and transform medicine but must ensure the public trust. If engaging the public is the way to do it, how can the people here today get more involved?”

Edwards answers: Continue conversations like this one, join book groups, bring all of this up during dinner with friends.

Raise these issues and get people thinking about them. This is not straightforward, so we need more people thinking about it and we need more and different ideas. Jen Wroblewski and NWABR can help put book groups or other conversations together and Edwards and her colleagues at UW would love to have more public conversations — so get in touch, http://www.nwabr.org/about/contact.html and http://depts.washington.edu/bhdept/facres/kfe_bio.html.

Russell points to The Immortal Life of Henrietta Lacks by Rebecca Skloot, which tackles some of the ethical issues involved. NWABR has prepared a discussion guide which can be used personally or by anyone wanting to facilitate discussions — download it in PDF format, here.

Russell also mentions a recent article in Newsweek, “The Prematurity Puzzle – Research on early births could hold clues to disorders like autism and cerebral palsy.” Her advice is to read and engage in all of this.

Sewards concludes: contact your local representatives if you have any concerns. The rights of research subjects are codified by the federal government and we want to make sure you are aware of your rights!

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Read on below for the moderated panel discussion before public questions and answers, and see a guide to all posts on this blog, here. — Brian Glanz for NWABR

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How are biorepositories best governed?

Sorensen asks the panel: “How are biorepositories best governed?”

Sewards answers first, describing that there are federal regulations which it is their job to implement. “We look at ‘gatekeeping’ in IRB-speak. Who is the researcher approaching, what are they collecting, where is it being placed, what are the security measures? What is the purpose of the repository? Who will have access and how do you keep track?”

In other words, they look from the beginning to the end of the process. They especially have many regulations related to whether data are stored and released with due respect to privacy.

Edwards answers that “It depends on the purpose of the biobank.” They often advocate for dynamic governing because research and our understanding is changing a lot, and because we are just starting into these areas historically speaking.

Edwards continues: some old tools like consent forms may now be outdated. You can tell people up front a certain amount or number of things, but you may need to get back in touch later when the research changes or more researchers want to be involved or do different things with the data or specimens. We need new and more flexible strategies for communications and data management, including personal interactions of participants with their own data and with the research in general.

Russell notes: “We have two IRBs plus a utilization committee looking at scientific validity. We are looking at ways of harmonizing across sites and forming some standard operating procedures, but we are also talking about the bioethics of all of it.” They are actively addressing these questions and do not feel they have it all figured out, yet.

Sorensen asks Sewards: “Who is on these IRBs?” and her answer: UW faculty, people from the community, students, lawyers — the full gamut of who makes up our society — as required by federal regulation. Scientific expertise is important but so is the general public component.

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Historical abuses and public trust

Sorensen asks: “Have historical abuses discouraged too many from participating?”

Edwards answers: Public trust is huge, whether working with a historically disadvantaged or abused population or just the general question of public trust in institutions.

We don’t have health care for everyone in America. In places like Canada and England, there tends to be more enthusiasm in signing up for a population based study because people feel they benefit from the research. Public health and a more comprehensive system ensures greater protection for and benefits for participants.

That’s a problem in America both generally and especially in populations like African Americans who have suffered particularly infamous abuses like in the Tuskegee syphilis experiment. Some Native American tribes keep control of data, sharing with only the projects they are interested in.

Edwards closes by observing that there is a breakdown in communication, both with specific populations after research is completed and with the public in general. People aren’t getting the feedback they expect from scientists.

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Data collection and privacy

Edwards describes that there are a variety of decisions being made about how specimens are collected, how much information to keep, and on what are minimum standards of privacy and security in various areas.

She asks everyone in the room — do you know that you have, or do you think that you have, your own specimens or data in a biobank? About half the room raises a hand, many tentatively. Edwards then explains there are many ways our tissues or data are collected that we may not be aware of, even being collected at birth.

There are two trends in biobank privacy. In one, greater anonymization has led to stripping more personal identifiers from samples and data.

Another trend is in the opposite direction, though: in some repositories, a tight link is being kept between personal identifiers and a person’s samples and other data. Advocacy-based biobanks tend toward this trend.

The reasons include that people can manage and access their own data and larger medical and/or research profiles. In some cases, people can track the use of their data in research.

This latter trend is more complicated, ethically and practically, but it may also lead to greater benefits in science and in public understanding.

Russell notes that GAPPS enrolls women at their first pre-natal visit, not knowing who may end up with a pre-term birth or other relevant circumstance. This is a very expensive operation, but even so they spend a lot of time in education and in verifying that strict rules have been followed to collect enough and valid data.

Sewards then describes the issues in greater detail — when do you ask for consent? What does the consent form look like? A concern of hers is adding greater context to consent.

Will large biobanks lead to breakthroughs?

Sorensen asks the panel: “Experts are claiming that large scale biobanks are going to lead to [scientific] breakthroughs. Is that true?”

Sewards replies first: Having different varieties of specimens and data together is very powerful, as is having one place researchers can go to get data. Greater variability and generalizability are the wins.

Edwards adds: For a while it seemed like everybody was starting their own repository, whether governments or institutions. Scaling up has benefits but do we really need to scale up in this way, or are we doing it in the best way over all, is there too much redundancy?

Edwards continues: Operating biobanks at larger scales creates larger scale ethical questions as well. Quality suffers with samples and data from repositories, in some cases, and even ethics quality can suffer. In one significant case, the State of Texas was required to destroy 5 million samples in a biobank due to a parents’ group lawsuit. The details of the case aside, its result was a scientific loss for everyone involved.

The biggest breakthrough we’ve seen is in cancer research — such as determining which chemo will work for which person. A lot of the biobanks forming now are specific to a single disease, such as autism.

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Introducing our panelists

Moderator Gretchen Sorensen introduces our panelists:

Kelly Edwards, PhD is Associate Professor, Department of Bioethics and Humanities at the University of Washington School of Medicine. Edwards is core faculty for the Institute for Public Health Genetics and the Critical Medical Humanities Research Cluster. For more, see her bio in the Department of Bioethics and Humanities.

Edwards describes the questions she helps others consider in her work as a bioethics consultant, often regarding biorepositories. Questions are sometimes  about recruitment and communications to potential recruits, such as “How should we handle consent?” Other questions surround data access, i.e. who has or should have access to data from the repository?

Shannon Sewards is Assistant Director for Operations, Human Subjects Division at the University of Washington. “What is ‘the human subjects division’ all about?” muses Sorensen, noting the intriguing name, before answering simply that it’s “anything that involves research on a person.” For further clarification we offer the following, from the division’s home page:

“Research involving human subjects must be reviewed and approved by an Institutional Review Board (IRB). At the UW, several IRB committees serve this function. The Human Subjects Division (HSD) provides administrative support and facilitates IRB review; assisting researchers throughout the process.”

Sewards describes that the role of IRBs is to be protective for the general public, while they can be a hindrance, relatively speaking for researchers.

Donna Russell, MHA is Director of Research Development and GAPPS at Seattle Children’s. GAPPS is the Global Alliance to Prevent Prematurity and Stillbirth, whose expanded mission includes maternal, newborn, and child health with a global scope.

Russell notes that GAPPS began because of the magnitude of the problem of pre-term birth, here in the U.S. and globally. 13 million pre-term births happen annually around the world, and 1 million of those are fatal. There are also 3 million still births.

That means there are more than ten times the number of still births as there are “SIDS” deaths. SIDS is relatively well publicized while still birth is not.

We still, fundamentally do not know what causes many of these deaths. The best strategy for solving the mystery is to link high quality specimens to descriptive data.

Therefore a cornerstone of GAPPS is their biorepository. They just started collecting data in the last year, after two years of preparation and addressing many of the issues we will discuss today.

A fundamental ethical question for GAPPS is that pregnant woman are a vulnerable population.

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Edwards, Russell, and Sewards are introduced by Sorensen