Lead Abetment

Sandra Adrianne Pena

Concordia University

Research Ethics in Public Health

MPH 560

February 27, 2014

LEAD ABATMENT1

Lead Abetment

  1. Could this study have been done, as a practical matter, if the families enrolled in the study were more affluent, for example, affluent enough to live in lead-free homes or to hire private lead testing of their properties?

I find it difficult to accurately answer this question with the supplemental information that I am discovering as I do research to determine what side of the issue I fall on. I believe that any well informed/educated family looking for a home for their young family that one of the first questions asked would be when the house was built and if it contains any lead paint. I believe the low-income community of Baltimore was taken advantage of. We as professionals know that any informed consent is not typically written at a level that can be understood by individuals that lack substantial education. And surly the Clinical Investigation Consent Form was probably numerous pages that could be overwhelming to anyone. And as an investigator eager to see a program succeed I can see how when reviewing the consent with participants only highlighting the positives like the provided transportation and the payments for completed questionnaires. I feel that a severe act of omission has occurred in these cases which lead to taking advantage of a situation.

  1. What is the relevance for the ethical assessment of this study of the "current reality" that landlords would simply abandon their properties if the highest, most effective, and most costly lead abatement measures were required in order for them to rent their properties? How can the reality of this assumed "current reality" be determined? Would it be relevant to the assessment of this study if it could be predicted that landlords would generally be willing to invest, for example, $1700 per property for lead abatement? How is the "current reality" of housing economics in Baltimore similar or dissimilar to the "current reality" of the lack of public health infrastructure and funding for HIV treatment in developing nations?

It is the case that many landlords are trying to make the most money without spending a lot of money. With that being said $1700 is a lot of money that money was given simply as a loan and money that they would need to payback eventually. So, the ethical question is are the landlords being willingly and intentionally ignorant and if so what are the legal ramifications? If it is something that a landlord owns and is abandoned due to the nature of costly repairs and the home is later inhabited by squatters do those squatters have a legal right to sue for exposure? I think an important question would be to ask the value of the homes if the lead abetment is valued at $6,500, but the home is only worth 10,000 and the landlord owns the entire block that consists of ten homes that $6,500 quickly turns into $65,000 for a $100,000 investment. The investor would quickly be underwater. When the questions is asked to relate this topic to HIV treatment in 3rd world countries I think some (not I) may say it just cost too much and to let it go. Well ignoring the problem is part of the reason that HIV/AIDS has become a global pandemic.

  1. Is it relevant to the ethical evaluation of this study that most, indeed almost all, of the participants probably benefited, i.e., most lived in houses more free from lead than they otherwise would have? Did the KKI researchers rely on the "background level" of risk of lead poisoning to justify offering less than maximally effective interventions in the course of the study?

I liken this situation to the one where a woman sued after she spilled coffee in her lap stating that she wasn’t aware that the coffee was hot. Everything has potential consequences or problems. We learned about the problems created by working in mines (black-lung) years after the exposures began. Same story with asbestos originally we didn’t know about the grave health consequences we didn’t put that insolation into homes to knowingly cause harm and death once we learned of the problem we condemned building and demanded a safe clean-up. My research indicates that in this timeframe 1993-1995 that poverty levels in Baltimore were just below 10% which is quite high I believe that many other homes where contaminated with lead paint and these people sued because they saw an easy pay day. But do they have a case if they signed an informed consent? I believe that these homes were far more safe than unsafe as the abetment had already occurred.

  1. How, if at all, was the design of the study faulty? Would the study have been unethical even if the researchers had reported testing results to parents in a timely fashion? What other measures, if any, should the researchers be required to undertake to protect the enrolled children from dangerous lead levels? At what blood lead level should such measures be undertaken (refer to Fact Sheet)?

How were the reports not timely? Did they (participants) not have access to the lab reports after the month one testing that included blood work and soil samples and all of the results for subsequent testing? If those results were not made available to the participants I could easily see how they could claim that they were not given results in a timely fashion. Knowing the health concerns that are linked to lead-poisoning it is important to know that there is no “safe” level of lead in the blood, but levels of 10 or more mcg/dl (micrograms per deciliter) is generally considered the threshold for concern, since at this point intelligence, behavior, and development can be adversely affected (Fact Sheet: Kennedy Krieger Institute Lead Abatement). So should any of these reports come back with any level of lead an action plan needs to be created since no level of lead is considered safe.

  1. Is the informed consent document revealing enough? What information should researchers be obligated to disclose in this study? Although regulations govern the elements of disclosure in the research context is there other information that should be disclosed to prospective research participants? What would a "reasonable person," or a typical parent in this situation, want to know? How should researchers respond if a prospective participant expresses the desire for more information?

I believe that the main points of the informed consent document both positive and negative need to be pinpointed and each should require an initialed acknowledgement that way no one can claim that they were uninformed about what exactly was taking place as each bullet point would be reviewed with the participant at the time of signing the document. Maybe if the monetary benefits came at the end of the study people would be more inclined to ask relevant questions. I believe that the parents in a way were short sighted as I would NEVER knowingly expose my child to a study where I knew lead was a possible issue as the above questions informed us that no level of lead is considered safe. If a participant asked for additional information it could be incredibly unethical not to mention illegal to not provide the information requested and open the agency conducting the study to the potential for huge lawsuits.

  1. Finally, is there anything about this study that is similar to the Tuskegee Syphilis study?

In our readings for the week we were provided with information about the Tuskee Syphilis study and one of the first ethically rich questions asked in that study was its use of deception to complete the study. Where the individuals in Baltimore deceived? It asks how to define or identify that vulnerability and I think a perfect example is low income, low SES, low education. In some communities in developed countries some individuals live on less than $5 dollars/day so an additional $15 can mean longer survival. So in conclusion I do believe that there are some striking similarities between the two cases and it is saddening that we have not learned from the past and things that happened almost 100 years ago and we are sure to continue to experience the same problems if we don’t start to learn from the past mistakes we have made.

References

Fact Sheet: Kennedy Krieger Institute Lead Abatement

Mastroianni, C & Kahn, J.P. (2002). Risk and Responsibility: Ethics, Grimes V Kennedy Krieger, and Public Health Research Involving Children. American Journal of Public Health (7), 1073-1076.

Parker, L. S., Alvarez, H. K., & Thomas, S. (n.d.). The Legacy of the Tuskegee Syphilis Study. Retrieved from