Scientific and Ethical Approaches for Observational Exposure Studies

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Background Information
Steps to develop the document
Final Document

Background Information:

EPA's National Exposure Research Laboratory (NERL) in the Office of Research and Development (ORD) has prepared a document on scientific and ethical approaches for observational exposure studies through recommendations from an expert panel, public comment, and external peer review. The final document, titled The Scientific and Ethical Approaches for Observational Exposure Studies (EPA Report No. EPA/600/R-08/062)(PDF) (133 pp, 1.2MB) identifies key scientific and ethical issues and provides information and resources to assist researchers as they plan and implement observational exposure studies. The document recognizes that researchers will work with others - EPA's Human Subjects Research Review Official, Institutional Review Board (IRB) members, the participants and their community, and other stakeholders - to identify and address all of the relevant issues for any specific study to ensure that all participants are respected and protected.

For more than two decades, EPA has conducted observational exposure measurement studies to measure people's contact with chemicals in their everyday environments during their normal daily activities. These studies involve measurements of chemicals in environmental media (e.g., air, water, food, soil, and dust); collection of information about the voluntary study participants, their homes, their work environments, and their activities; and analysis of voluntary human samples such as blood or urine to determine the amounts of contact. In EPA's observational measurement studies, participants are not exposed to chemicals as a result of being in the studies. That is, these studies neither involve intentional exposure of the participants nor a change in a person's behavior or environmental conditions in an attempt to impact the participant's exposure.

EPA's observational studies collect information that is critical to meeting the goal of improving public health. In these studies, EPA identifies the chemicals that people are coming in contact with; the concentrations of those chemicals; the most important sources of those chemicals in people's lives; and when, where, how often, and why people come into contact with chemicals in the environment. The information collected in observational studies can be used to better understand potential risks and health effects from chemicals in the environment and to develop risk mitigation strategies and methods.

EPA strives to follow the most up-to-date approaches in designing and performing observational exposure studies. These approaches are developed by experts in academia and various Federal agencies. EPA wants to ensure that the Agency's observational exposure studies continue to be based on the most up-to-date sound science and the highest ethical standards. To meet that goal researchers in NERL have compiled information that can be used by researchers conducting these studies.

Steps to develop the document

To gather information for the document, EPA held an expert panel workshop on November 28 - 29, 2006 to discuss state-of-the-science approaches for observational exposure measurement studies. The 11-member panel discussed their ideas for the content of the document and the state of the science for various elements of observational exposure studies. The panel agreed that the document planned by EPA should include the following six major topic areas:

Elements to be considered in study conceptualization and planning,
Ensuring protection of vulnerable groups,
Privacy, confidentiality, and other concerns related to observational human exposure measurement studies,
Creating an appropriate relationship between participant and researcher,
Building and maintaining appropriate community and stakeholder relationships, and
Designing and implementing strategies for effective communication.

The workshop discussions and panel recommendations are summarized in a final report for the workshop (PDF) (142 pp, 1MB).

EPA has used an open and transparent process to develop the document that included briefings to stakeholders, solicitation of public comment, recommendations from nationally-recognized experts, and external peer review. As part of this process, the draft document was submitted to EPA's Human Studies Review Board (HSRB) for external peer review. The HSRB is an advisory board established in accordance with the Federal Advisory Committee Act. As described in the Agency Charter, the HSRB provides advice, information, and recommendations on issues related to scientific and ethical aspects of human subjects research. The external peer review by the HSRB was consistent with their charter because observational studies involve human participants (i.e., human subjects) and the issues discussed in the draft document are related to scientific and ethical aspects of human subjects research.

The HSRB discussed the review comments at their meeting on October 24, 2007 in Crystal City, VA. The review comments were published in the October 24-26, 2007 EPA Human Studies Review Board Meeting Final Report (PDF) (85 pp, 418.8KB), on the Human Studies Review Board Web site.

EPA also released the external review draft document for comment by the public during a 45-day public comment period. The public comments and the response to comments are posted on EPA Docket Number EPA-HQ-ORD-2007-0972.

Final Document

The external draft review document has been revised in response to the comments from the public and the HSRB. Copies of the final Scientific and Ethical Approaches for Observational Exposure Studies (PDF) (133 pp, 1.2MB) document, in addition to being available on this website, will be available from the National Technical Information Service.