Conference Report On: “Dialogues for Improving Research Ethics in Environmental and Public Health”



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Conference Report On:
Dialogues for Improving Research Ethics
in Environmental and Public Health”


May 30 – June 1, 2003 at Brown University

Providence, RI


Compiled by:

Dianne Quigley


Principal Investigator

Tel. (315) 443-3861; email:diquigle@syr.edu

www.researchethics.org

Conference Report on a “Dialogues for Improving Research Ethics in Environmental and Public Health
TABLE OF CONTENTS:

Conference Background and Sponsorship. ………………………………………… 2
Conference Purpose and Objectives ………………………………………………… 2
Summary Overview of Conference Panel Presentations…..……………………….. 2
Conference Panel Presentations……………………………………………………... 6
(1) Research Protections and Institutional Needs for Community Research ………… 7
(2) Promoting Community Rights in Research .……………………………………… 10
(3) Reshaping Science for Environmental and Public Health …………………….. .. 16
(4) The Status of Funding for Community-Researcher Partnerships ………………… 22
(5) Institutional Review Boards and Institutional Protections ……………………….. 26

(6) Research Ethics and Community Partnerships. ……………………………………. 32

Conference Plenary Discussion: Outcomes and Recommendations………………… 40
Conference Participants and Feedback……………………………………………… 48
Conference Postscript………………………………………………………………… 50
Conference Participant List …………………………………………………………… 51




Acknowledgements:
The Collaborative Initiative for Research Ethics and Environmental Health is funded by a grant from the National Institute of Health, National Institute of Allergies and Infectious Disease Grant Program for Research Ethics – T15 A149650-01 We thank Linda Silka, Carol Williams and Phil Brown for their editorial assistance with this report. We also thank Dawn David of the Akwesasne Task Force for the Environment and Doug Taylor and Jessica Henry of the Southeast Community Research Center, Atlanta, Ga. for their assistance with conference planning and organizing. We thank all the conference speakers for their rich contributions for improving research ethics.

I. Conference Background and Sponsorship

The national conference “Dialogues for Improving Research Ethics in Environmental and Public Health” was sponsored by the “Collaborative Initiative for Research Ethics in Environmental Health” as a part of its project activities under a National Institute of Health grant program for Short Courses in Research Ethics. The Collaborative Initiative is administered through Syracuse University and brings together an interdisciplinary team of public health, social science, biomedical and behavioral researchers, including several ethicists in public health from four collaborating universities: UMASS, Lowell, University of North Carolina, Chapel Hill, Tufts University and Brown University and the Southeast Community Research Center, Atlanta, GA. The interdisciplinary team all are involved in community-based participatory research projects and collaborate with community-based researchers in promoting project activities. The project focuses on research ethics with culturally-diverse populations (i.e. Native Americans, Southeast Asians, African-Americans Chinese and Hispanic populations) and community health studies. The investigators not only develop courses with an emphasis on the problems and challenges of culturally-diverse populations, but each investigator produces important case studies and articles (see website:www.researchethics.org). The conference was organized in the project’s third year with this purpose and objective.

II. Conference Purpose and Objectives

This conference sought to bring together community representatives, academic scientists, government researchers and funders in the field of environmental and public health to facilitate a dialogue on important research ethics issues. Through case study presentations and panel discussions, the conference organizers sought to generate new recommendations, tools and resources for dealing with the difficult challenges of key research ethics issues that were identified by the interdisciplinary team and community health organizers through the project’s outreach and training activities.


After two years of the project team’s outreach of short courses to researchers and community populations in other regions of the United States, important feedback was gained about research harms to communities, skills and training needed by researchers in the field, and ethics policy recommendations that need to be promoted. These six panel topic areas had emerged as priorities for conference panels from our short course presentations (1) Research Protections and Institutional Needs for Community Research (2) Promoting Community Rights in Research (3) Reshaping Science for Environmental and Public Health (4) Perspectives on the Status of Funding for Community-Researcher Partnerships (5) Institutional Review Boards and Institutional Protections and (6) Research Ethics and Community Partnerships.

The highlights of these panel presentations are discussed below.

III. Summary Overview of Conference Panel Presentations – Issues and Needs

Thirty-three panel speakers were recruited for the conference panel topics from around the country. This included racially diverse researchers (Native American, Asian, African-American, and Hispanic) as well as a mix of government, academic and community-based researchers in the field (see speaker list at www.researchethics.org). We prepared a conference booklet of abstracts for the speaker presentations which can also be found on our website.

A. Research Protections and Institutional Needs

This panel presentation highlighted community-based innovations needed for dealing with community research harms. Innovations are needed that will overcome the conduct of scientific research that offers no benefits to communities, the exploitation of community members in research activities, and the failure to inform communities of risks and benefits of research. Panel presentations provided models of community control (i.e. a community research councils) and described successful strategies in community collaborative participation that have been developed by two community-based research programs. A tribal group discussed how their community research councils function to allow and disallow research depending on whether the research is consistent with a set of community criteria. Additionally, community reseach council exercises control over data ownership and dissemination. Also discussed was the model of a regional center in the Southeast that provides infrastructure support to assist communities with research protections and provides information to communities on participatory strategies for engaging in health research with academic researchers. Another speaker highlighted the important role that community members can play on institutional review boards (IRBs) with federal agencies and universities to ensure ethical research. Discussants also noted the complexities that remain to be addressed in building a community around human subjects, such as defining affiliated and unaffiliated members; victims, subjects, activists, geography and participants.


B. Promoting Community (Group) Rights in Research

This panel held two sections; the first section provided an overview of the complexities in establishing community rights for research that are extensions of individual rights. The second section stressed community field experiences in seeking rights in research.

In the first section, the project team members debated the need for community rights. The project’s principal investigator began by arguing that the ethical principles that exist for individual rights should be extended to communities. A list of ethical innovations developed from a compilation of community health studies in Native communities demonstrated how beneficence, justice and autonomy can be protected by (1) training community members on risks and benefits of standard health research methodologies; (2) developing partnerships with community members through research design, training, data collection, shared control and infrastructure support; and (3) the integration of the local knowledge of the community with the more quantitative research data. The project ethicist argued that at present no established principles on group rights in research exist. In trying to establish them, a number of moral complexities face us, such as: when does a group become worthy of separate ethical consideration? How should informed consent guidelines be modified to take into account particular group characteristics? How does the researcher deal with competing group representatives from one community? How can the problem of community stigmatization from research results be addressed? How should questions of ownership of data and results be addressed? How are individual rights protected when the community owns the data? The third speaker, an anthropologist, has written of the need for emergent ethics in situational contexts where there are different power differentials and where cultural and racial differences exist in community partnerships. Codes of ethics can become problematic when applied to many of these differing research contexts.

A second section focused on community rights in research brought forth field stories from community-based organizations that have engaged in collaborative research with academic and government scientists where questions have been raised about how community rights can be protected. Struggles for shared control over research were highlighted such as when a research department uses a community project for its benefit and in doing so override community consultation and control mechanisms. Additionally, communities (particularly culturally-diverse communities) become, in effect, guinea pigs for multiple research teams that provide few benefits to the community and frequently do not even report findings back to the community. Mechanisms for control were described such as creating a research center administered by a community controlled organization and inviting scientists and policy-makers to be part of the governing board .Some important ethical challenges were raised here for community rights, including problems of community stigmatization from environmental contamination results, issues of access to state controlled cancer and/or community-generated data, and the responsible reporting of data back to study participants.

C. Reshaping Science for Environmental and Public Health

Two sections of this panel were conducted and included presentations on Native science methods as models for more integrated, holistic research approaches. Additionally, several presentations highlighted issues in western science that address limitations of “objectivity” as defined by mainstream science and the courts. The Akwesasne multi-tier definition of health incorporates a research design that includes cultural and traditional practices as a part of the research effort. A risk assessment study that is culturally-based may produce findings that go beyond measuring levels of PCB in fish to include losses of language, cultural practices, and relatedness with the earth. Research methods may stress conversing with elders, radio shows and mentoring relationships. Similarly, a research model for studies of fish contamination from the Yakama Indian Nation is entitled the “medical ecological model” (or medicine wheel) and includes four interrelated components: ecology, epidemiology, cultural study and clinical medicine. Such an approach produces a rich data collection that reflects the interaction of these components. Another speaker described basic principles of Native science as written by Gregory Cajete and how objectivity is gained through subjective processes. She highlighted the need for community members to become local knowledge-producers in order to inform this type of objectivity. Another speaker described a new method in the practice of western environmental health science, that of “weight of evidence” whereby no single study is used to determine causality but rather a number of studies including qualitative data become a part of a subjective weighting system. This approach is focused on a social level and not on how to prepare for court law suits that limit how science is used. Another speaker then described the Daubert challenges as the way courts will decide causality when faced with uncertainties in data; courts usually rely on reductionistic methods and frequently keep out testimony based on innovative scientific methods that incorporate the community reporting of health harms.

D. The Status of Funding for Community-based Participatory Research (CBPR)

For most community groups seeking to increase the ethical research taking place around the country, the biggest challenge they report facing is the lack of funding support for CBPR. Two speakers from federal agencies that support environmental health research (i.e., NIEHS and EPA) discussed the ways in which their agencies have committed to CBPR and they spoke of successes that have emerged from their programs such as community empowerment, community capacity-building, and policy impacts such as institutional changes to scientific practices and funding priorities. Some challenges in funding decisions were discussed such as the performance of evaluations and providing greater assistance to partnerships in order to ensure their success. A community speaker highlighted the important need for communities to have control over research funding to ensure its ethical outcomes. An academic speaker reflected on the benefits and challenges to academics involved in CBPR research projects. Academics involved in CBPR usually lose peer support in their department but nonetheless, the speaker recommended the need to create institutional change in universities to legitimize CBPR and bring more university support to the problems of communities.

E. Institutional Review Boards (IRBs) and Institutional Needs

Four presenters highlighted the importance of community participation on IRBs and the need for IRB guidelines to include protections for communities. A speaker from Indian Health Service (IHS) presented the work of IHS IRBs focused on maintaining the important principle of “Respect for Communities;” this principle should include a set of guidelines that require evidence of community (tribal) approval, cultural sensitivity, community partnerships in each stage of research (including publication), and a listing of benefits to the communities from the research. Another speaker highlighted concerns about strengthening the ways in which lay involvement is integrated into academic IRBs; thoughtful attention needs to be given to how lay involvement is defined, how community members can participate equitably with academic representatives, and what training is provided. Other models of IRBs should be considered that might better ensure the community’s independence from academic control and provide more accessibility to the research process for communities. Concerns were also raised about informed consent for population studies. Who are the appropriate providers of consent, particularly in very culturally-diverse communities? How is training conducted on the benefits and risks of health studies, as well as the burdens and benefits of informed consent? Two other speakers echoed concerns about a clash of interests and values when community people participate on academic IRBs. It was noted that there can be a disconnect about important values represented by CBPR; academics may need to be trained on CBPR and communities may need greater training on IRBs and their processes. Also there is a need for relationship-building between two groups. Power differentials can be hidden by so-called “objectivities”. There are conflicts of interests if universities are dependent on certain funding sources. Lay person is too broad a term when there are multiple kinds of research (environmental, public health, genetic) and multiple needs for representation (those with certain diseases, those from certain neighborhoods). It is too problematic to develop a ‘one size fits all’ prescription for community involvement on IRBs. These challenges require investments of training funds to IRBs, funding for community involvement in IRBs, a process to address inequities and power differentials on IRBs and guidelines to overcome conflicts of interests between community needs and university funding needs. Many recommended the need for community review boards to ensure ethical research.

F. Research Ethics and Community Partnerships

Key ethical challenges continue to emerge within community-academic partnerships. These issues include how partners seek to balance power, how academics gain community input and integrate community knowledge, how to build capacity and promote institutional change define the work of partnering. This panel held three sessions with six speakers who addressed many of these issues based on their personal experiences in the field. Community-based speakers highlighted the importance of including scientific research activities in their campaigns for social change that centered on improving the quality of life in their communities. Urban speakers spoke of common issues with contamination through air pollution from waste facilities, diesel exhaust, and other industrial activities that expose multi-ethnic city neighborhoods. Technical studies of air monitoring, environmental sampling and mapping of disease incidences often engage these communities in partnerships with universities. Speakers outlined important considerations they have encountered in working with research partners, including the need for up-front agreements about community control over the process, skills-building for community members (such as in youth projects), inclusion of qualitative data that captures the community’s experience with contamination, the identification of concrete actions that will benefit the community from the research, and translation of research results for the community.

Both academic and community presenters highlighted the difficult challenges to partnerships from unequal power differentials, specifically white privilege issues and powerful academic institutional values that can dominate the research interactions. Mutual trust and understanding must be exercised through listening and a sharing of each other’s contexts and values. Partners need to be aware of each other’s daily constraints in meeting common goals and have a shared accountability to each other. One speaker stressed a need for structures and norms to guide processes of working together and offered two case examples of this. Several spoke of celebrating our differences in coming together and allowing conflicts to emerge as part of a dance of sharing power together. Most supported the need for resources and time in developing partnership relationships before research begins. Such an approach would allow culturally-diverse communities to ask research questions that derive from their own experience and not merely from previous scientific studies. One speaker urged an opening of “hidden transcripts” of community members who lack the trust in researchers to reveal their true opinions and needs in the partnership.

One academic speaker stressed the importance of attending to building research partnerships from the very outset and addressing the “when” in the research process as well as the “what.” (e.g., at the very outset communities and researchers developing hypotheses together, residents should not be objects of research but should be involved from the very outset in setting research agendas, developing the research questions, and conducting the research.) In other words, community partners should be participants in all project phases. Another spoke extensively about the importance of using qualitative methods (i.e. community narratives and data collection) to enrich the scientific goals of research; such methods should include “member validation” processes that allow community members to review and critique initial research data analyses. Several speakers emphasized the benefits to universities and scientists of community research studies and that institutional reform is needed in universities if more CBPR activities are to take place.
IV. Conference Panel Presentations – Full Report
This section includes a full report of conference presentations from transcriptions, notes and papers from speakers. The list of speakers and presentations is included below, followed by transcriptions and summaries of their presentations.
Panel One - Research Protections and Institutional Needs

Treena Delormie and the members of Onkwatakari’tahtsheran Health and Social Services Research

Council, Kahnawake, “Community Models for Building Research Protections

Jodi Sugerman-Brozan, Alternatives for Community and Environment, Roxbury, MA, “Building Successful Community-University Research Collaborations”

.Susan Rose, Human Subjects Program Manager, U.S. Dept. of Energy, Wash. DC, “Community as Community IRB Member”


Doug Taylor, Director of Southeast Community Research Center, Atlanta, GA, “Building Networks to Assist in Community Research Protections”

Panel Two - Promoting Community (Group) Rights in Research

Section One: Project Team Presentation from the Collaborative Initiative for Research Ethics in Environmental Health on Complexities of Establishing Ethical Guidelines for Group/Community Rights

Dianne Quigley, Principal Investigator for Collaborative Initiative for Research Ethics in Environmental Health, Syracuse University

Ann Gold, cultural anthropologist, Syracuse University.

Ernest Wallwork, ethicist, Syracuse University

Section Two: Field Experiences with Gaining Community and Group Rights

Omega Wilson, Director; West End Revitalization Association, Mebane, NC,

Julia Brody, Director of Silent Spring Institute, ”Models of Community Empowerment in Research on Breast Cancer and the Environment”

Niem Kret, Executive Director, SABAI

Panel Three - Reshaping Science for Environmental/Public Health Research

Section One:

The Inadequacies of the Western Scientific Method in Environmental Health Research

Steve Wing, University of North Carolina, Dept. of Epidemiology, Chapel Hill, “Application of Daubert”

Sheldon Krimsky, Tufts University, MA, “Reflections of the Weight of Evidence” in toxicological studies


Doris Cook, lakoti’satstensserakwis Ne Ohontsia Project, Akwesasne Task Force on the Environment (ATFE), “Strengthening our Relationship with the Earth”


Section Two:

Incorporating Indigenous Sciences into Environmental Health Research Activities

Lori Lambert, Salish Kootenia College, Pablo, Montana “Inclusion of Traditional Knowledge in the Assessment of Community Impacts

Chris Walsh, Yakama Indian Health Clinic, Toppenish, Washington, “Contaminated Fish and the Concern for Tribal Health”

Dianne Quigley, Syracuse University “Deepening the Ethics of Environmental Health Research Through the Use of Multiple Knowledge Systems

Panel Four - Perspectives on the Status of Funding Community-Researcher Partnership

Shobha Srinavasan, National Institute of Environmental Health Sciences, Raleigh, NC; ‘Community-based Research at NIEHS”

Barbara Driscoll, Policy, Planning and Standards Group, U.S. Environmental Protection Agency, NC, “Funding Community-based Partnerships for the Air Toxics Program”.

Gary Grant, Concerned Citizens of Tillery, NC, “Ethics of Community –Researcher Partnerships”

Cynthia Lopez, Epidemiologist, UMASS-Lowell, ”The Joys and Frustrations of Participating on Community-owned Research Projects”

Panel Five - Institutional Review Boards and Institutional Protections

Francine Romero, Northwest Portland Area Indian Health Board, “The Fourth Basic Ethical Principle: Respect for Communities”

Peggy Shepard, Executive Director and Co-Founder of West Harlem Environmental Action (WE ACT); “Can IRBS Assure Informed Consent in Community-based or Population Research”


Nancy Shore, University of WA, “IRB Review Processes for Community-based Participatory Research”

Lisa Eckenwiler, Executive Director of and Senior Research Scientist at the Center for the Study of Medical Ethics and Humanities, Duke University Medical Center “The Role of Communities in the Ethical Review of Research”

Panel Six - Research Ethics and Community Partnerships

Section One: General Considerations in Community-Academic Partnerships

Linda Silka, UMASS-Lowell Center for Family, Work and Environment

Swati Prakash, WE ACT, West Harlem, NY,

Section Two: Issues of Race, Class and Cultural Contexts in Community Partnership

Vivian Chavez, Dept of Health Education, San Francisco State University, “The Dance of Race and Privilege in Community-based Participatory Research”

Amy Schultz, Dept. of Health Behavior and Health Education, University of Michigan, “Mediating Values, Contexts and Traditions in Community-Academic Partnerships”

Section Three: Community Knowledge Creation, Research Designs, Action Outcomes

Phil Brown, Brown University, Sociology Dept. “Qualitative Methods in Environmental Health Research”

Marta Segura, Communities for a Better Environment, Los Angeles, “Partnership Successes of the Communities for a Better Environment”

A. Panel One - Research Protections and Institutional Needs in Community Research

In our experience with conducting short course workshops nationally from the first grant period, the project team became aware of a number of culturally-diverse communities that are seriously affected by environmental contamination but have no local resources for training researchers on research ethics in environmental health. They are not aware of research protections that they could ensure in their relationships with researchers. These presentations are informative for community groups and researchers in ensuring ethical research on the community level.

Community Models for Building Research Protections” The Kahnawake (Mohawk Tribe) Research Council, Montreal, Canada; Treena Delormier, Carolyn Walker and Linda Deer

Treena Delormier began the presentation by stating that due to an increasing number of research requests coming to the community, the community’s social service and health agency needed to develop a mechanism of community control over this. They established a community-controlled research council in the year 2000 with a policy statement and guidelines for operation. The council includes one agency member and three volunteer community members. Its tasks and tools include to (1) dialogue with researchers on the council’s role and their role (2) review and discuss proposed research and give researchers applications if they don’t have a proposal prepared (3) once projects are approved, they are tracked with recordkeeping that has to be done, (4) we facilitate approved research with community support for projects that will be helpful, (5) we document research for projects that are disallowed and state how it is not beneficial to the community. In these ways the council screens research proposals.

Favorable research projects are those that have direct benefits to the community. Projects should respond to a justified need in the community. Research projects must be participatory and collaborative and demonstrate that there is capacity-building for the community. Research projects are disallowed if (1) they did not have a justified need (2) they are seeking rubber stamp approval (3) they do not seek the community as a partner and (4) they don’t respect the protocol in place for research. There are no arrangements for community partnership and the research is not relevant to community needs. Treena gave an example of a health study where the community forged a collaboration with the federal government. The project was considered a success as there was cooperation all along. A lot of education about the diseases were conducted in the community. The project hired community members. Even though the research could not achieve statistical significance, there was community capacity-building that made it successful. An example of disallowed research was a project to study family violence that threatened the community with disruptive research activities. These activities would damage trust among community relationships. The research intent was primarily that Kahnawake was close to where the researchers lived so it would be easy for them to do this project.

Another community member discussed how the tribal reserve is located along the St. Lawrence Seaway, near major routes for air, water and rail industrial transportation and many smaller communities. There are many potentially hazardous threats to the community from these transportation activities. The speakers highlighted the administrative responsibilities that are important to consider in overseeing research. This includes the tracking of the research investigations, ensuring there are reports filed and that accountability is maintained. Meeting minutes, on-the-job training in research and administrative functions, research review and assessment are other important and time-consuming responsibilities.

(Please see slide presentation in the Conference Booklet.)

________________________________________________________

Jodi Sugerman-Brozan of Alternatives for Community and Environment (ACE) in Roxbury, MA; Building Successful Community-University Research Collaborations. ACE’s organizational goals are to build the power of low-income communities of color to eradicate environmental racism and build environmental justice. ACE provides direct legal, social, and community organizing activities and co-directs a youth leadership project. ACE is always being approached by many researchers for studying health and asthma issues. Jodi discussed projects in asthma and air pollution that ACE conducted in successful collaborations with local universities that brought many benefits to community members and were highly participatory. She described the effective work ACE conducted with the Harvard School of Public Health (NESCAUM) and the MA Dept. of Environmental Protection on implementing a community-based air monitoring program (AIRBEAT) which included youth volunteers. Roxbury had asthma rates 22 times higher than other communities. The residents of Roxbury set up air monitors in key areas of air pollution and produced data that led to a significant change for cleaner diesel fuels in buses; community education on air monitoring and air pollution; and improved quality of service in bus transportation for residents. Through the use of air monitors, ACE conducted effective education and community outreach for residents about pollution that then led to improvements.

ACE offers these recommendations to communities engaging in research with universities and government agencies. These include (1) ensuring that the university builds relationships with the community before conducting research and not just writing letters of support for researchers to get funding; (2) ensuring equitable relationships – there should always be equitable funding arrangements for all partners and shared decision-making over research issues; (3) real community ownership and empowerment – residents shouldn’t be objects of research but should be involved in setting research agendas, developing the research questions, conducting the research and participating in all project phases. Research funds should be used to hire people from the community. Community education and outreach should be integrated along the way.

____________________________________________________________

Susan Rose, the Human Subjects Program Manager of the US Dept. of Energy, “Community, as in Community IRB Member” spoke of her commitment in ensuring that community subjects of research be represented on Institutional Review Boards. Such definitions of community have multi-meanings and can include – subjects, participants, victims, geography, activists, recipients and advisors. At the Department of Energy, worker communities are her major concern and developing their representation in IRBs is challenging as it is not standard procedure for many IRBs to include community representation. Both IRBs and community members need to understand the need for this participation. As such, Susan Rose spoke of large conference she organized to educate many different types of communities of the need to be involved in IRBs. She disseminates newsletters to thousands of people asking for their concerns about Human Subjects Research. The response from the subject populations is low but she is working on building it up. Susan highlights four major considerations in the conduct of research that protects human subjects. These include (1) attention to women’s issues in research (2)attention to community values (3) benefits to participants must be apparent both before and after the research and (4) the research has to be transparent and collaborative.

__________________________________________________________


Douglas Taylor, the Executive Director of the Southeast Community Research Center (SCRC), “Building Networks to Assist in Community Research Protections.” Doug Taylor spoke of the importance of regional centers for promoting and assisting with community-based research projects. He described the emphases and activities of SCRC in Atlanta, GA which is organized specifically to assist communities in the Black Belt of Alabama, Mississippi, Louisiana, Georgia and North and South Carolina. With high poverty and disease rates, low levels of income, education, and infrastructure, the SCRC is conducting CBPR research to improve conditions in these areas. Some of the objectives of the SCRC for this work include:


  1. to build and support democratic institutions and policies in research activities.

  2. create infrastructure for social change and linking various institutions to promote this.

  3. create new tools and partnerships for social change, including CBPR.

  4. put knowledge creation in the hands of the left-out.

  5. move resources to where they are needed and overcome inequities in research where one-half billion dollars is spent on research in the South with little or no funding for CBPR.

  6. to provide project-specific expertise, to partner with community organizations in the Southeast to conduct needed research.

Doug Taylor then described these principles of CBPR that are followed by the SCRC



  1. to conduct research that benefits the community and meets the goals of the community.

  2. community participation at every stage of the research.

  3. power-sharing in the research activity.

  4. respect for the expertise and knowledge of all research partners.
  5. to learn from existing codes of ethics to develop a specific code of ethics at the initial stage of research.


  6. to include a specific action agenda – what will the community get out of this.

  7. co-ownership of data and credit and recognition for all partners.

He provided brief descriptions of the SCRC’s work in projects with the Alabama Black Belt communities and their health issues, a project for tools for change with the HBCUs (Historic Black Colleges and Universities) of Atlanta, GA and a “Road Map of Health Disparities” from the view of the community being developed in Jackson, MI. He emphasized the need to think about social determinants when looking at health disparities such as poor housing, food sources and stress levels). Doug Taylor encouraged the creation of regional community research centers all over the US. Such centers need to be directed by community leaders and need to stay open and flexible in looking for unexpected openings.


B. Panel Two - Promoting Community (Group) Rights in Research

This panel held two sections; the first section provided an overview of the complexities in establishing community rights for research that are extensions of individual rights. The second section stressed community field experiences in seeking rights in research.


Section One – Establishing Ethical Principles in Environmental/Public Health

In the first section, the Syracuse University project team members of the Collaborative Initiative for Research Ethics in Environmental Health” discussed the challenges of established principles for community rights.

Dianne Quigley, the Syracuse University principal investigator, “Ethical Innovations in Community Research” set out ethical principles that exist for individual rights that should be applied to communities. A list of ethical innovations developed from a compilation of community health studies in Native communities demonstrated how beneficence, justice and autonomy can be protected by (1) training community members on risks and benefits of standard health research methodologies; (2) developing partnerships with community members through research design, training, data collection, shared control, capacity-building and infrastructure support; and (3) the integration of the local knowledge of the community with the more quantitative research data. She stated that these innovations are needed to protect communities against research harms that have actually occurred. Such harms she cited were: the exclusion or dismissal of important community knowledge about local disease, contamination and potential exposure scenarios which led to technical inaccuracies in research results; the data collection biases and cultural insensitivities of researchers who subsequently ignore distinct lifestyle habits and subsistence information that affect exposure and disease estimates; the use of weak study designs that produce inconclusive results which then shut down future research by demonstrating no compelling need for further public health follow-up in an affected community; the interpretation of study results by academic researchers solely which lead to selective interpretations of data that may downplay significant data results; the researchers’ use of community resources, data and labor of community members for research activities that confer no benefits on community members and lead to exploitation of the community; and research teams that produce series of adversarial findings in communities where several studies may show health impacts but then are disproved by other teams. This also leads to a lack of public health follow-up and protection. She stated the important need to (1) educate communities of risks and benefits of research to ensure comprehension as part of informed consent and (2) to allow communities a choice in researchers and their investigations as necessary to respect for autonomy.

(Please see full paper in Conference Booklet.)

______________________________________________________


Ernest Wallwork, Syracuse University, project ethicist, “Ethical Analysis of Group Right for Research Ethics in Environmental Health”, argues that there are no established principles on group rights in research. As our society stresses individual rights, it narrows the broad concerns of traditional ethics to the immediate problems of isolated individuals. He discusses the emphases of utilitarian cost-benefit calculations and Kantian ethics which hold respect for the autonomous decision-maker as ethical values that dominate bioethics and research ethics. These are impoverished vehicles for ethical deliberations on group rights as they focus on persons apart from their social traditions, institutions, roles, shared goals and environments. IRBs and principal investigators then need to translate moral principles and rules designed for individuals to collectivities. In trying to establish ethical principles for groups and collectivities, a number of moral complexities face us, i.e. when does a group become worthy of separate ethical consideration? How should informed consent guidelines be modified to take into account particular group characteristics? How does the researcher deal with competing group representatives from one community? How do we protect communities from community stigmatization from research results? How do we deal with the questions of ownership of data and data results? How are individual rights protected when the community owns the data? Dr. Wallwork then reviews case studies produced in the SU Research Ethics Project and how the different authors try to interpret ethical principles for groups from individual rights. Dr. Wallwork concludes by stating that the partnership ideal usefully suggests that our research ethics for groups or communities needs to be jointly negotiated and constructed among mutually respectful participants, willing to be changed through dialogue about how to cooperate in joint undertakings. (Please see full paper in Conference Booklet.)

____________________________________________________

Ann Grodzins Gold, Syracuse University anthropologist, “Research Ethics from the Cultural Anthropologist Point of View”, had written of the need for emergent ethics in situational contexts with different power differentials and cultural and racial differences in community partnerships. In her paper, 'Research Ethics from the Cultural Anthropologist's Point of View", Dr. Gold writes that in the field of anthropology, universalizing codes of ethics can become problematic when applied to differing research contexts. She discussed several field examples from anthropology where ethical violations occurred in ways that are not anticipated so that codes can’t always prepare one for ethical conduct. Given these circumstances, other anthropologists, cited by Gold, recommend an ethics of doubt and dialogue where the ethical relation is always worked out in emergent ways. Dr. Gold reflected that, after listening to speakers at this conference, she was more convinced of the need for published ethical codes. In health research these may be important reference points for communities suffering injustices.

(Please see full paper in Conference Booklet)
Section Two - Field Experiences with Community Rights

A second section brought forth field stories from community-based organizations engaging in collaborative research with academic and government scientists and how community rights can be protected and/or violated.


Omega Wilson, the Executive Director of the Western Environmental Revitalization Organization in Mebane, North Carolina discussed the challenges of community rights in research in his community. These are the general highlights.
  1. Anyone seriously interested in protecting the “research rights” for historically African-American communities must begin with an appreciation of the need to overcome fear and mistrust.  Fear and mistrust prevents community members from sharing private or personal information, advocating for their own rights, contributing to shaping research questions, choosing sampling locations, and asking critical questions about the research and its applications.  The African-American communities in Mebane share a history dating back to land acquired by freed slaves. This history affects many aspects of interaction and communication--community knowledge sharing, views of outsiders (regardless of ethnic background), and experiences of environmental injustice.


  2. Grassroots community-based organizations need to be involved in research projects as ‘partners’ not ‘subjects’ or guinea pigs. Specific examples will be shared of the basis for mistrust in research institutions and of how community members were helped to become comfortable enough to be able to participate in an EPA Environmental Justice study.

  3. The prospect of research grants may increase susceptibility of communities to research exploitation because researchers may attempt to appropriate the community story to use it for their own ends. This can impact the integrity of data collection, interpretation, and lead to research that is more designed for ‘academic’ use rather than ‘applied’ uses that directly contribute to problem resolutions in communities where data was collected. Specific examples will be shared of two grants that were turned down due to this problem and how attorneys have been engaged to develop guidelines to protect the interests and legal rights of the West End Revitalization Association and communities it represents.

Background; WERA was organized in 1994 by low-income and African American residents of 135-year old West End and White Level Communities when threatened with destruction by plans for the 27-mile four-lane 119-Bypass/Interstate from Mebane to Danville, VA. Local governments and the N.C. Dept. of Transportation/Federal Highway Administration planned the 119-bypass/interstate project for fourteen years without input from residents to service mega industrial park anchored by Ford Motor Company’s new east coast distribution plant.

WERA and local residents filed administrative complaints at the U.S. Department of Justice in 1999, regarding plans for the 119-Bypass/Interstate that would destroy West End and White Level Communities. Highway engineers reported that 87% of the “displaced” homeowners would be low-income minority homeowners who were denied participation in the planning process. In violation of the federal laws, plans included displacement without relocation of at least 77 houses, two churches, and a Masonic temple. St. Luke Christian Church’s cornerstone date is 1893 and Mebane First Presbyterian cornerstone date is 1864, before the Thirteenth Amendment was ratified to end slavery.


WERA’s board is composed of stakeholders from five Mebane African-American communities in Alamance and Orange Counties. WERA received its 501-©3 nonprofit status in 1995, and became the first community development corporation (CDC) in Alamance County in 1997 with start-up funds from the N.C. Rural Center and Z. Smith Reynolds Foundation. In 2001/02, WERA became Alamance County’s first Community-Based Environmental Protection (CBEP) organization with funding and training from EPA and the Environmental Support Center, Washington, D.C.

The Issue: “WERA’s Right to Research Data and GIS Mapping


  1. In 2001 EPA Region 4 awarded WERA a $15,000 Environmental Justice Small Grant to collect data of failing on-site septic systems and contaminated drinking well water in three African-American communities in Mebane’s extraterritorial jurisdiction (unincorporated areas just outside city limits). Community residents helped to design a questionnaire and completed 120 door-to-door. Residents were also trained to collect drinking water and surface water samples.

  2. WERA planned to complete the 12-month study with three partners: a) university lab for testing water samples for contamination (financed by fees and graduate school thesis project), b) demographic data and GIS mapping (grants), and c) legal counsel that will use research study results to support WERA’s legal strategy (pro bono).

  3. PROBLEMS:
    1. Jointly applied for grant ($30,000) was awarded and GIS mapping partner attempted to force WERA to sign a university contract that made WERA a “subcontractor,” the university “principal investigator,” and WERA’s “expert witness” without consultation. GIS mapping partner threatened to withhold mapping if WERA did not sign contract.


    2. GIS mapping partner submitted a second grant ($60,000) application as WERA’s agent without authorization.

    3. WERA discovered that GIS mapping partner maintained a business relationship with a firm that helped plan the mega industrial park that threatened displacement of West End homes.

    4. WERA used legal counsel partner to severe relationship with GIS mapping partner and void two approved grants totaling $90,000.

  1. SOLUTION: Legal counsel partner is developing WERA contract to protect rights, community privacy, and data results with collaborative partners.


Case Study Questions: WERA’s Best Chance to Protect Research Rights: Collaborate and Partner with a Private University, Public University, or sign a contract with a Commercial Consultant?

  1. What are the pros or positive sides of with each? (Private University, Public University, Commercial Consultant) What are the cons or negative sides of with each? Which would you choose and why?

NOTE: Please forward your Case Study responses to WERA’s email at wera1usa@netscape.net or fax to (919) 563-8857. Thank you for your reply. Omega R. Wilson

_________________________________________________________

Julia Brody, the Executive Director of Silent Spring Institute (SSI),” Models of Community Empowerment in Research on Breast Cancer and the Environment,” stated that SSI was founded to study women’s health and the environment, specifically dealing with breast cancer incidence. SSI is part of the legacy of Rachel Carson who spoke of the rights of citizens to be in their own homes without poisons. Few people were aware that Rachel Carson had breast cancer.

Breast cancer incidence is higher now than at any other time. The SSI seeks to forge partnerships between activists and researchers and has been investigating the high incidence of breast cancer on Cape Cod, MA. SSI was founded by the MA Breast Cancer Coalition and is based in Boston and Cape Cod. The SSI has core values in its research work: (1) research is conducted in partnership between community members and researchers (2) prevention is a major goal and (3) the Institute supports innovation and high risk research which is not funded by traditional sources. SSI scientists work in collaboration with researchers at BU, Harvard, Tufts and the US CDC. The Institute is a non-profit organization with a public interest board of directors that includes leaders from the Massachusetts Breast Cancer Coalition. This direct role for activists in governance of a research organization distinguishes SSI from other CBPR models. Silent Spring Institute’s largest study, the Cape Cod Breast Cancer and Environment Study, was funded by the MA State Legislature ($1 million/year) through the MA Dept of Public Health but this funding has since been eliminated. The SSI is now funded through private foundations and federal grants.

Nurturing the research-activist partnerships of SSI requires outreach to the public on an ongoing basis. This is conducted mainly through the SSI website and news media. SSI also has a research center, advisory committee, and full-time outreach coordinator on Cape Cod. There are community poster sessions by scientists at community events. At the beginning of its research

efforts, SSI solicited input from many community members through focus groups. Dr. Brody stresses that there was a scoping period before research goals were set. She emphasized the need to be in dialogue with scientists on their turf through peer-reviewed scientific journal publications and conferences. Communicating with the scientific community is important, because scientists are so heavily involved in health policy decisions that offer the opportunity to translate research into action.

The Cape Cod study included environmental and biological sampling in 120 homes, an aspect of the study that was strongly supported by the community. Eighty-nine chemicals were measured, with a focus on endocrine disrupting compounds, especially those that mimic estrogen. SSI also conducted an epidemiological case-control study of 2100 women with and without breast cancer. Residence was traced back to the 1940’s. The study targeted chemicals in household products (hair sprays, disinfectants, toys, detergents, etc.) and air and drinking water contaminants. The household sampling program detected 67 chemicals, including 23 pesticides; DDT, chlordane and other chemicals that have been banned are still found in homes. GIS mapping assessed historical exposures to pesticides used for golf courses, gypsy moth sprays, cranberry bogs, and other agriculture; and to drinking water contaminants. Pesticide exposures were assessed by linking residence locations with information about wind direction, forest buffers to limit aerial drift, and other parameters. Dr. Brody mentioned some potential adversarial interactions with the chemical manufacturers that were resolved by assessment of split samples sent to a second laboratory for analysis. .

The ethical issues most challenging to SSI include:


  1. Who has access to public health information. For example, the MA Cancer Registry is running behind with data publicly available only until 1999. In reporting Cancer Registry statistics, there are issues regarding the levels of aggregation by town, census tracts, or regions and by time periods. The Registry is now choosing shorter time periods, 3 years, so there will be fewer cases and less statistical power.

  2. Community stigmatization and legal complications are a potential problem as measurements of groundwater or well water can set off a state or federal investigation which could lead to superfund status, and sampling results may affect real estate values.

  3. Access to information about environmental exposures can intersect with private property issues. They had difficulty getting multi-family private property owners to allow environmental testing.

  4. Reporting to individuals about exposures in their homes is a complicated situation as the health effects for some of these environmental exposures are poorly understood, and in some homes there are high levels of exposure. It is not known if they are episodic or long-term.

  5. Control and access to data are problems as the MA Dept of Health wanted Silent Spring to submit research data to them and destroy the study team’s copy. An agreement was reached to allow the study team continued access to the data.

Dr. Brody ended by thanking the women of Cape Cod for their participation in this research.

_____________________________________________________________

Niem Nay Kret, the Executive Director of Southeast Asian Bilingual Advocates (SABAI), which provides services in Lowell where 17000 or more Cambodians make their home. The word representing her group is “Sabai” which also means empowerment in Khmer. She became involved in the community around issues of health and the project her group is a part of (other partners include Lowell Community Health Center, Cambodian Mutual Assistance Center, Visiting Nurses Association, and University of Massachusetts Lowell) is funded by CDC to

prevent heart disease and chronic diseases among Cambodian Americans. As a part of the project—Cambodian Community Health 2010--the partnership performed a study, constructed a survey, and translated the work for the community. Many of the issues discussed today speak to issues her community is struggling with. One difficult problem for them is that there is little in the way to track research. Researchers often want to come and write a story or do a study on the Cambodian community. Cambodians frequently become subjects of research because of the oppressive conditions they suffered in their homeland. In Lowell, they live in lower economic areas that have improved and are being revitalized. The Cambodian community continues, though, to experience pressures from researchers to participate in research.

For Cambodians, issues of language are very important. For example, the word “organization” which has been used frequently through this conference and is used by community groups, is associated in the minds of many Cambodian Americans with communism. For people with more education that word may just mean organization, while for those with less education the term is seen as referring to a group of people who decide whether you live or you die. At Sabai, they use the word department rather than the word organization. Niem Kret continued by discussing some of the urgent needs within the Cambodian community. One is a need for information about causes of various health problems. Another is the need to build community resources (resources on community values, knowledge of services used, community insight, cultural diversity). Such resources, together with an increased ability to access these resources, can promote improvements in living conditions

In conducting research activities, the Cambodian community’s first priority is the need to make ends meet. As a result, community members probably won’t ask why a research survey is being done and they probably will not see how it is relevant to them. Their focus is on daily living and needing to make ends meet. Ms. Kret described the example of a group that did a survey on the Cambodian community a few years ago but the community never received information about the results. It turns out that the survey was done largely so that that someone could get a PhD because in American society you need a letter in front of your name if your knowledge is to be valued and respected. The experience of the community is that there was a survey done but no one heard about it and it made few differences in the lives of those in the community. This is a common problem in the Cambodian community. The survey was on post-traumatic stress (PTSD) because of war in Cambodia. When the researchers come in they may have good intentions but the important question is, do they leave the community for the better?

A participant in the audience asked Ms. Kret about cross-cultural misunderstandings when it comes to traditional healing practices. There was a discussion of a traditional practice of cupping and how the practice might raise concerns about child abuse. In the Cambodian community there is little belief that surgery will automatically take care of a problem. Older people do not want to have surgery for glaucoma, for example, so they use this practice of cupping that leaves burn marks on the skin. Cambodian traditional customs are those that emphasize herbal medicine. Unfortunately the practice of herbal medicine is being lost because many health care practitioners do not have the background information here. Pregnant women use herbal medicine after delivery; the particular herbs can give a false appearance on a blood test that someone is drunk. Traditional healers might use the Gecko lizard or the blessed string for healing. A monk is also sometimes brought in to bless the sick person. An audience participant asked if: you shared some of the practices for physical ailments, are there similar ones for mental illness? Ms. Kret responded that she worked in an out-patient clinic. We hardly ever talk about mental illness, but a monk would be brought in to work with a patient. There is a doctor who did a lot of work on PTSD with Cambodian community and has information on ways of addressing mental illness and trauma in the Cambodian community. Rather than going to a counselor Cambodians are likely to prefer to talk to the monk.

C. Panel Three - Reshaping Science for Environmental and Public Health

Two sections of this panel were conducted and included presentations on Native science methods as a model for more integrated, holistic research approaches. Additionally, several presentations highlighted issues in western science that address limitations of “objectivity”: as defined by mainstream science and the courts.

Section One – Native Science and Western Science Limitations

Doris Cook; Researcher from the Akwesasne Task Force for the Environment, “Strengthening Our Relationship with the Earth”, highlighting the Native research approaches of the ATFE with environmental health research in their community. Ms. Cook presented this material on behalf of Mary Arquette, the Executive Director of the ATFE. The Akwesasne Nation is located along the northwest border of New York State and intersects the international border with Canada. In the 1950s, the Moses Saunders Power Dam was constructed, resulting in a major impact on the community residents. The dam, created to harness the power of the river in order to produce electricity, has since disrupted the agrarian livelihood of the people in the area who once relied heavily upon the fish for sustenance. In addition, several industrial production facilities have been constructed in the area due to the dam’s production of electricity. The Akwesasne nation is located downstream from these facilities, putting the people at great risk.

The Akwesasne Task Force on the Environment recently convened the “Dreaming Our Future Conference” to assess the impact of a culturally-sensitive approach to environmental health research. This approach, based on having a good mind, body and spirit attempts to reorganize cultural traditional values and practices of the Mohawk people in way that benefits the health of the nation. One of the key elements of this approach is improving Mohawk language competency, which itself is a major part of the culture. Also identified was the need to strengthen community government and its ability to make environmental decisions. All of this is linked to the need to remediate pollution and restore the natural environment. The research questions produced by the conference were how do we use culture and tradition in environmental health research? And how do we develop strategies from within the Mohawk nation that can be portable to other communities? Another problematic component of traditional research is the use of the risk assessment model, which focuses on a single disease and utilizes a step-by-step approach to identifying the cause of a disease.

For the tribe, a different perception of health is dominant; one that is culturally informed. For the Akwesasne, the concept of health is more holistic and integrated. For them, the traditional western biomedical model is meaningless. For example, an EPA scientist came into the nation to complement a measure to reduce PCB exposure through the elimination of fish consumption. For the EPA, this was seen as a victory. For the Akwesasne, this was a loss of tradition and culture, as well as a loss of the omega 3 protein they received from the fish. New research methods were identified by the conference. One new methodology would be conversing with elders, using radio shows to communicate with tribe members, and developing long term mentor relationships. These methods recognize the complexity of information obtained through the interview process.

So the three ethical principles of the Akwesasne nation are having a good mind, peace and strength. These are all related to privacy, autonomy, integrity and trust and play out in their relationship with the environment.


Based on these methods, a complex model of research results was presented. These results center around language and the interaction of many factors. They focus on how cultural traditions play out in everyday life and how sustenance was originally maintained. The Akwesasne view of health is multi-tier. It starts with the individual, who is found with in a family. That family is part of a clan, who is a member of a larger community. The clan is part of a people who are part of a confederation. The confederation is a part of the earth. This system of integration is grounded in the relationships with those who have passed on. When we compare this model of health to the environment, there are great similarities.

To summarize, the Akwesasne multi-tier definition of health incorporates a research design that incorporates cultural and traditional practices as a part of the research effort. A risk assessment study that is culturally-based may produce findings that go beyond measuring levels of PCB in fish but highlight losses of language, cultural practices, and relatedness with the earth. Research methods may stress conversing with elders, radio shows and mentoring relationships to restore health and cultural losses.


(Please see full paper in Conference Booklet.)

_____________________________________________________


Sheldon Krimsky, Ethicist from Tufts University, “Prosecuting Toxic Chemicals without Causality – Implications for Community Research”

In the historical narratives describing the development of natural science nothing captures the drama of discovery as effectively as the “crucial experiment” (an experimentum crucis). For it is such an experiment, according to most historical accounts, that finally resolves competing explanations and/or theories, bringing to a close contested schools of thought. It was a “crucial experiment” that put to rest the theory of spontaneous generation in favor of the germ theory of disease, and that launched a critical blow to the Phlogiston theory of combustion. It was a also crucial experiment in the early part of the 20th century carried out by British physicists, among them Sir Arthur Eddington, who made use of a solar eclipse to measure the bending of the sun’s rays, an observation that supported Einstein’s over Newton’s theory of light.

There is a significant and lively debate on whether crucial experiments actually exist, pitting Karl Popper against Thomas Kuhn, where the latter was a leading voice against the view that scientists falsify theories. Nevertheless, there are influential experiments that crystallize a new scientific consensus.

It is very rare to find such experiments in environmental health sciences. A single well-constructed experiment almost never resolves a critical issue on the cause of a disease, particularly but not exclusively, diseases resulting from exposure to toxic substances. As long as we do not permit experiments where we would intentionally harm a human subject for the sake of scientific inquiry, no single experiment can provide the decisive data on the effects of a substance on a human group. With tens of thousands of hazardous waste and contaminated groundwater sites throughout the United States, many communities are justifiably concerned about the human health effects. The conclusions reached by health and regulatory agencies for establishing a causal connection between toxic chemicals and adverse health effects are often at odds with the perception of affected populations. Moreover, even when there are statistically significant disease clusters, there is scarcely a case where skepticism about the environmental cause of the cluster does not frame the debate and invalidates the claims of community activists.

It is not unusual for important public health decisions to be based on non-causal data. Consider, for example, the recent published study of hormone replacement therapy for post-menopausal women. There were about 4,000 women in the study. A two fold increased risk of Alzheimer’s was found among women on the hormone therapy. There was no causal determination in this epidemiological research and yet it will guide medical practice.

Likewise, there are other approaches for evaluating chemicals effects on communities that do not depend on a “causal determination.” They include weight of evidence, unexplained rise in illnesses, gradient in illness frequency, disease clusters, and other types of circumstantial or noncausal forms of evidence. Epidemiologists have tried to bring causality around the back door by establishing criteria for extrapolating from association to cause. The Bradford-Hill Criteria is the most common among these. The Bradford-Hill criteria suggest that you can make the inference from association to causality when the data have certain characteristics. And while it may be true, if there is a causal effect, these other effects will be present, it is still a dubious inference to interpolate from properties of the data to causality.

In so far as we depend on a number of experiments, some with greater statistical power than others, and information from diverse epistemic modalities, we need to have some way of aggregating or weighing the results across different attributes of evidence. The term “weight of evidence” (WOE) is used to characterize a process or method in which all scientific evidence that is relevant to the status of a causal hypothesis is taken into account. In criminal law, juries are given the responsibility to decide the WOE in regards to guilt or innocence. For the policy sectors of government, regulatory agencies or risk assessment panels use WOE to assess the total value of the scientific evidence that a substance may be dangerous to human health. Sometimes the term is used as if there were some algorithm or rational decision process by which the “weighing of evidence” is accomplished. Other times, the term “weight of evidence” refers to nothing more than a subjective assessment on the part of a reviewer, who takes relevant data into consideration, based on a given body of published research, to ascertain whether a hypothesis is more likely to be true than false.

A distinction has been made between “weight of evidence” and “strength of evidence.”2 The latter is associated with the gravitas and relevance of information related to specific indicator such as the number of tumors produced in animals. In contrast “weight of evidence” includes all varieties of evidence, positive and negative, mechanistic and non-mechanistic, in vivo and in vitro, as well as human and animal studies. In risk assessment, the trend has been to widen the lens of relevant empirical and theoretical evidence, thus moving from approaches that utilize “strength of evidence” to those that utilize “weight of evidence. “A number of benefits to a weight-of-evidence framework in regulatory decisions have been noted in the literature: 1) it provides a “clear and transparent framework” for evaluating the evidence in a risk determination; 2) it offers regulatory agencies a consistent and standardized approach to evaluating toxic substances; 3) it helps to identify the discretionary assumptions in risk determinations from experts.




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