Open house: the ethics of studying children at home.Home is where the heart is, but for children, home all too often can be where the danger is--danger of exposure to lead, asthma triggers, pesticides, safety hazards, and other potential sources of harm. Those risks are disproportionately common among poor and minority children, whose families more often lack access to decent, affordable housing.
In recent years, environmental health scientists have increasingly sought to identify and ameliorate a·mel·io·rate
tr. & intr.v. a·me·lio·rat·ed, a·me·lio·rat·ing, a·me·lio·rates
To make or become better; improve. See Synonyms at improve.
[Alteration of meliorate. risk factors affecting such children. Research into housing-related health hazards involving children has proven to be an area of investigation both rich in potential for discovery of effective intervention methods and fraught with opportunities for ethical lapses. A recent report by the National Academies now provides researchers and their sponsors clear guidelines to avoid ethical pitfalls while aggressively pursuing new and beneficial knowledge.
A 2001 decision by the Maryland Court of Appeals The Maryland Court of Appeals is the supreme court of the U.S. state of Maryland. The court, which is composed of one chief judge and six associate judges, meets in the Robert C. Murphy Courts of Appeal Building in the state capital, Annapolis. cast a spotlight on the ethics issue. In the case Grimes Grimes is a surname, that is believed to be of a Scandinavian decent and may refer to
Shortcomings may also be:
Although Grimes v. Kennedy Krieger Institute was eventually settled out of court, the appeals court comments threw the field into a state of confusion as its ethical underpinnings were called into question. Ultimately, this uncertainty led the major federal funders of this type of research--HUD, the CDC See Control Data, century date change and Back Orifice.
CDC - Control Data Corporation , and the EPA--to ask the National Academies to appoint a committee to examine the issues in detail and recommend procedural and policy changes to clarify best practices and resolve ethical dilemmas.
The Committee on Ethical Issues in Housing-Related Health Hazard Research Involving Children, Youth, and Families, a project of the National Research Council and the Institute of Medicine, was carefully chosen to represent a variety of stakeholders Stakeholders
All parties that have an interest, financial or otherwise, in a firm-stockholders, creditors, bondholders, employees, customers, management, the community, and the government. in this research enterprise. "We were diverse in terms of background and professional training," says committee chairman Bernard Lo, a professor of medicine and director of the Program in Medical Ethics medical ethics The moral construct focused on the medical issues of individual Pts and medical practitioners. See Baby Doe, Brouphy, Conran, Jefferson, Kevorkian, Quinlan, Roe v Wade, Webster decision. at the University of California, San Francisco . "We had scientists who do housing research, and we had several members who were very familiar with low-income housing and were advocates for people in low-income housing. Those are the sorts of viewpoints that needed to be included, supported, and recorded."
Peeking into Scary Closets
A variety of ethical concerns coalesce co·a·lesce
intr.v. co·a·lesced, co·a·lesc·ing, co·a·lesc·es
1. To grow together; fuse.
2. To come together so as to form one whole; unite: to make housing-related health hazard research particularly challenging. It takes place in the home, with an inherent invasion of privacy invasion of privacy n. the intrusion into the personal life of another, without just cause, which can give the person whose privacy has been invaded a right to bring a lawsuit for damages against the person or entity that intruded. . While in the home, researchers may notice hazardous conditions other than those under study--what is their responsibility in such a situation? The community may have expectations of and desires for ameliorative a·mel·io·rate
tr. & intr.v. a·me·lio·rat·ed, a·me·lio·rat·ing, a·me·lio·rates
To make or become better; improve. See Synonyms at improve.
[Alteration of meliorate. research outcomes that are vastly different from those of the investigators. Many health hazards (such as lead-based paint) occur disproportionately in poor-quality housing occupied by low-income, often ethnic minority families, so children in these families are the most likely candidates for study. This can lead to concerns about exploiting vulnerable groups of subjects for research that ultimately benefits others. Parents in these families are often poorly educated; this, combined with the typical complexity of informed consent forms, makes it difficult for them to provide meaningful informed consent for their children's participation. Also, inappropriate financial and other incentives may unduly influence parents' decisions regarding their children's participation.
The committee met five times over the course of 18 months to examine these issues. The panelists heard presentations from committee members and external experts, including parents, community leaders, researchers, government officials, and specialists in law and ethics. "Through those presentations, as well as their review of the literature and their deliberations, the committee came up with their consensus view on what ought to be done in this area," says Mary Ellen O'Connell, a National Academies staff officer who was the committee's study director. After the group's initial draft was reviewed by an external slate of reviewers with similar expertise and revised based upon their comments, the final report, Ethical Considerations for Research on Housing-Related Health Hazards Involving Children, was released on 19 September 2005. Lo says the committee unanimously supported all of the recommendations put forth in the report.
The report addresses specific recommendations to the three main audiences in need of guidance: researchers themselves, research institutions and institutional review boards, and the federal government and other research sponsors. The recommendations all revolve around Verb 1. revolve around - center upon; "Her entire attention centered on her children"; "Our day revolved around our work"
center, center on, concentrate on, focus on, revolve about two guiding themes: the need to involve community representatives at all stages of the research, from inception to follow-up, and the need to strengthen the process of informed consent so that parents fully understand the essential features of the research study. The report strikes an elegant balance, clarifying what have been ethical gray areas while still facilitating and encouraging housing-related health hazard research designed to improve the lives of the most vulnerable children and families.
Building a Firm Foundation
One key recommendation made by the committee is that all federal agencies sponsoring housing-related health hazard research should formally adopt the federal regulations addressing human subject research participation, particularly Subpart D of 45 CFR CFR
See: Cost and Freight 46, which provides additional protections specifically for child participants. The CDC and the NIEHS NIEHS National Institute of Environmental Health Sciences (NIH, DHHS) , as agencies of the Department of Health and Human Services Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979
Health and Human Services, HHS , are already governed by Subpart D. According to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. Lo, the EPA EPA eicosapentaenoic acid.
n.pr See acid, eicosapentaenoic.
n. has committed to formally adopting it, while HUD Hud (hd), a pre-Qur'anic prophet of Islam. Hud unsuccessfully exhorted his South Arabian people, the Ad, to worship the One God. has responded that it will follow the regulations and require their protections in their projects, but does not plan to make Subpart D part of its official policy, at least for now.
According to committee member Alan Fleischman, a senior advisor In some countries, a Senior Advisor is an appointed position by the Head of State to advise on the highest levels of national and government policy. Sometimes a junior position to this is called a National Policy Advisor. at the New York Academy of Medicine The New York Academy of Medicine was founded in 1847 by a group of leading New York City metropolitan area physicians as a voice for the medical profession in medical practice and public health reform. , the panel was particularly impressed with the amount of data supporting the value of community engagement in environmental health research--so called community-based participatory research Community-based participatory research (CBPR) is research that is conducted as an equal partnership between traditionally trained "experts" and members of a community. In CBPR projects, the community participates fully in all aspects of the research process. (CBPR CBPR Community-Based Participatory Research ). "It actually results in better, more focused research," he says. "There is increasing evidence that engaging communities actually makes the research more powerful, more important, and more valid, and the potential to develop advocacy approaches to do public health intervention health intervention Health care An activity undertaken to prevent, improve, or stabilize a medical condition and change is more effective." Further, subjects are better protected in that community involvement can act as kind of a buffer, ensuring that potential risks and benefits are well characterized and defined, and that there is far less potential for even inadvertent exploitation.
The committee recognized that in the real world the reforms they were recommending would translate into more time and more money being required for housing-related health hazard research projects. The panel addressed this reality by recommending that research sponsors provide the additional funding and extended timelines necessary to support expanded community participation. The report also suggests that "researchers need to develop ongoing partnerships with their communities, which is of course complex, and takes time and effort," says Fleischman. But in the long run, he adds, "individual research projects may not be slowed down, if in fact those projects are part of a portfolio of research being done with relationship to the community as partners."
Putting Out the Welcome Mat
By most accounts, the report has been received quite warmly. "This report was particularly important to us," says Rebecca Morley, executive director of the nonprofit National Center for Healthy Housing, which both sponsors and conducts research. "In order to do our research, we were looking forward to having very clear guidelines, because what we were finding is that the current [oversight approaches] had the ironic and perverse effect of discouraging the study of the most serious health hazards, and prompted researchers to shy away from Verb 1. shy away from - avoid having to deal with some unpleasant task; "I shy away from this task"
avoid - stay clear from; keep away from; keep out of the way of someone or something; "Her former friends now avoid her" studies that focus on communities at the highest risk, for fear of being seen as callous or discriminatory," she says.
According to Lo, feedback from HUD, the EPA, and the CDC has been positive. "They've already adopted some of our recommendations," he says. "They responded favorably, and they are obviously looking at the recommendations carefully, and hopefully they'll encourage all of their researchers to adopt them."
As an institute that has pioneered CBPR--in fact, often requiring community involvement in the research process--the NIEHS has also welcomed the refinements offered in the report. Children's environmental health program administrator Kimberly Gray says that although the institute already practices much of what the report preaches, it's good to get a wider outside perspective on the issues involved.
O'Connell thinks the tone of the responses to the report she's been hearing bodes well for acceptance and active adoption of its recommendations. She says, "People have been asking me 'how do we do this?' rather than 'why should we do this?'"
Rooms with a Long View
Of course, a committee report, however thorough and well-intentioned, cannot guarantee that ethical lapses will not still occur, that researchers might not still hesitate to pursue housing-related health hazard research projects for fear of litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.
When a person begins a civil lawsuit, the person enters into a process called litigation. , or that its recommendations and suggestions will be universally followed. But committee members are optimistic that the report will be viewed as a milestone in efforts to support and encourage such research while putting it on a more solid ethical footing.
"We believe that these are feasible recommendations that are well within the ability of researchers and sponsors to carry out, and that they will improve trust within the communities that they serve, and also strengthen parents' understanding of what this research is all about," says Fleischman.
Morley is taking more of a wait-and-see approach. "The proof will be in the pudding in implementation," she says. "As researchers actually start to apply this, I think we will see the practicality of the recommendations, and whether [the report] has delved into sufficient detail to enable researchers to operate with a clear conscience and also give participants peace of mind."