Human Exposure Monitoring for PBDE Derivatives

Timothy J. Ledbetter, D.Min., BCCKathy Ertell, MS, CIH

November 2009 Human Subjects Working Group

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The Sacred Salmon

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Project Overview

This study seeks to study Polybrominated Diphenyl Ethers (PBDE’s) and their structurally-related analogues: can they be reliably detected and measured in humans?PBDE’s are flame retardants; widespread aquatic contaminants, entering the human food supply through seafood & other foods.PBDE’s are environmentally persistent.PBDE’s concentrate in lipid-rich tissue.Fish is not the only exposure pathway: dust, breast milkHuman health concerns about endocrine disruption – estrogenic activity, thyroid hormone effects – and effects on neurobehavioral development.

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Project Overview

Highest body burdens found in USA, and in children.PBDE’s undergo biotransformation by fish and mammals, making exposure assessment difficult.Study will look for both PBDE’s and its metabolites, not just the parent compounds.No dataset of this type for a US population.Pilot study: can our analytical instruments detect and measure PBDE’s and their analogues in human biological materials?Pilot study could be a precursor to larger studies.

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Community Members Contributions

Community members provide…Common sense (“So what?” or “What difference will it make?” questions posed to PI’s and sponsors)Common language  (easily readable documents)Common awareness of community (socio-anthro-cultural)Example: suggested local Sunday Schools or Sabbath Schools as sources of children to participate in researchExample: suggested deeper consideration of cultural mores as way to honor participants

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Community Members Concerns

Monitor the evolution of approach to and consideration of persons who agree to be involved in a research project:

• Research objects (minimal regard for human dignity)• Tuskegee Syphilis Study

• Human subjects (acknowledge ethical responsibilities)• Belmont Report

• Honored participants (respect and value human person & community)• (what will establish this consideration?)

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Study Design

Recruit a population that eats large amounts of fish: Native Americans from a Puget Sound tribe who are subsistence fishermen.PI is familiar with the tribe and their fishery.Population is concerned about the safety of the fishery.Recruitment by flyers, email, tribal meetings.If participants consent, they keep a food diary for two weeks detailing fish consumption.One blood draw for analysis of PBDE’s and analogues.Store blood samples for 3 years, then destroy.

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Puget Sound Tribal First Salmon Ceremony

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The Community Perspective

A special population, with unique cultural normsStudies about Native Americans individuals are, by the nature of that culture, community studies.Community studies require a community perspective.Successful studies in the Native American community usually require buy-in and approval from the tribal governing council or board.If the tribal community doesn’t want it, it won’t happen.Tribes are tradition- and relationship-oriented.

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Challenges

Appreciating Native American population values.Cultural practices and expectations – how to conduct the study in a manner consistent with tribal beliefs and norms.Significance of fish in the culture.How does the tribe regard the taking and handling/ storage/disposition of blood? Additional analysis? Past issues with genetic analysis in the Navajo tribes.Establishing relationships and building trust.Privacy issues.Results not likely to be easily interpreted or understood.

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Resolution of Issues

IRB engaged a cultural anthropologist.Full Board Review not required, but conducted to gain input from community members.Recommendation to use person-to-person contact rather than mail, email, phone: recruitment meetings.Recommendation to leverage the tribal structure where trust relationships already established: • approval of tribal council• announcement of study at tribal meetings • use of tribal health center for blood draws• have tribal council distribute study summary

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Resolution of Issues

No allowance for future analysis of blood without specific consent.PI to work with tribal members to learn their preferences for disposition of blood samples (any rituals?).PI recognition of fish as a central and sacred part of tribal culture – use proper tribal names for fish.Results not to be given to individual participants, summary to be given to tribal council for distribution and possible discussion at meeting.Overall – tried to find ways to recognize the community and make the study transparent: community input, community discussion, community support, community participation, and community partnership.

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“Honored Participants in Research”

IRB community members can assist by:Understanding common and unique features and contexts of persons being recruited to participateWatching for “blind spots” when considering certain populations (more nuanced than present protected groups such as pregnant women, prisoners, children ,etc)Asking in IRB meetings: How does this research or participating in research help make us a better people and society?Balance the scientific and human needs for research.

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Honored Research Participants

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CONCLUSION: Community IRB members help research stay on the ball!

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