Whytest grime

Nonetheless, the majority appears to have decided the issue of whether such duty of care was, in fact, breached as a matter of law, without a hearing or a trial on the merits. I cannot join in the majority's sweeping factual determinations that the risks associated with exposing children to lead-based paint were foreseeable and well known to appellees and that appellees contemplated lead contamination in participants' blood, see id. Indeed, the majority recognizes that the record is "sparse.

The critical point is that these are questions for the jury on remand and are not properly before this Court at this time. I emphasize that we are deciding the propriety of granting summary judgment. Therefore, upon remand, appellee is free to offer evidence to support its position. Unfortunately, the majority chooses to go far beyond the narrow question presented in these appeals and addresses a number of ancillary issues in dicta.

I cannot join the majority in holding that, in Maryland, a parent or guardian cannot consent to the participation of a minor child in a nontherapeutic research study in which there is any risk of injury or damage to the health of the child without prior judicial approval and oversight.

Nor can I join in the majority's holding that the research conducted in these cases was per se inappropriate, unethical, and illegal, see id. Such sweeping holdings are far beyond the question presented in these appeals, and their resolution by the Court, at this time, is inappropriate. I also do not join in what I perceive as the majority's wholesale adoption of the Nuremberg Code into Maryland state tort law.

Finally, I do not join in the majority's comparisons between the research at issue in this case and extreme historical abuses, such as those of the Nazis or the Tuskegee Syphilis Study. Accordingly, I join the majority only in the judgment to reverse the Circuit Courts' granting of summary judgments to appellees. The Court has considered the motion for reconsideration and the submissions by the various amici curiae. The motion is denied, with this explanation. Some of the issues raised in this case, in the briefs and at oral argument, were important ones of first impression in this State, and the Court therefore attempted to address those issues in a full and exhaustive manner.

The case reached us in the context of summary judgments entered by the Circuit Court, which entailed rulings that the evidence presented by the plaintiffs, for purposes of the motions, even when taken in a light most favorable to them, was insufficient as a matter of law to establish the prospect of liability.

We disagreed with that determination. Thus, the cases were remanded for further proceedings in the Circuit Court. Every issue bearing on liability or damages remains open for further factual development, and any relevant evidence not otherwise precluded under our rules of evidence is admissible. In the Opinion, we said at one point that a parent "cannot consent to the participation of a child The context of the statement was a non-therapeutic study that promises no medical benefit to the child whatever, so that any balance between risk and benefit is necessarily negative.

As we indicated, the determination of whether the study in question offered some benefit, and therefore could be regarded as therapeutic in nature, or involved more than that minimal risk is open for further factual development on remand.

I respectfully dissent from the order denying the motions for reconsideration. I adhere to the views previously expressed in my concurring opinion filed herein on August 16, The majority's discussion of the ability of a parent or guardian to consent to the participation of a minor child in a nontherapeutic research study and the discussion regarding the ethics of the research conducted in these cases involve serious public policy considerations.

The statements are a declaration of public policy that, in the posture of this case, are best left to the General Assembly. See Gaver v. Harrant, Md. Inasmuch as these issues were never raised by the pleadings or the parties below, this Court had no basis to address these very complex issues; if a change is to be made in the State's policy of regulating research studies, unless clearly presented to the court, it should be made by legislative enactment.

See Md. Nat'l Bk. United Jewish App. This matter merits the close scrutiny of the General Assembly. See Cotham and Maldonado v. Board, Md.

Each IRB is required to have at least five members of varying backgrounds;. Each IRB has to contain at least one scientific member and one non-nonscientific member and one member who is not affiliated with the institution in any way.

No member of an IRB can have a conflicting interest. Subtitle A, sections One of the aims was to evaluate low-cost methods of abatement so that some landlords would not abandon their rental units.

For those landlords, complete abatement was not deemed economically feasible. The project would be able to assess whether a particular level of partial abatement caused a child's blood lead content to be elevated beyond a level deemed hazardous to the health of children.

The tenants involved, presumably, would be from a lower rent-urban class. At least one of the consenting parents in one of these cases was on public assistance, and was described by her counsel as being a minority.

The children of middle class or rich parents apparently were not involved. Those vulnerable subjects included prisoners, who are subject to coercion, [see The Prisoner's Cases: Clay v.

Martin, F. Lally, F. Prudden, 58 A. Orentreich, Misc. The complaint alleges that most of the patients selected were African-American and, in the vernacular of the time, charity patients. Studies show that the process of informed consent serves as a social filter: Better educated and wealthier individuals are more likely to refuse to participate and are underrepresented in most research.

The problem is perpetuated in pediatrics, where parents who volunteer their children were found to be significantly less educated and underrepresented in the professional and managerial occupations compared to their non-volunteering counterparts. Unlike the present case, the Navajos were not recruited by the researchers to be placed in the environment being tested for unhealthy substances.

See Zeleznik v. Jewish Chronic Disease Hosp. And see Application of Hyman, 42 Misc. Jewish Chronic Disease Hospital, 21 A. We resolve these issues in the context of the trial court's granting of the appellee's motions for summary judgment. Farfel was referring to children in general when making this remark.

The purpose of the study was manifestly not to reduce the level of lead in the blood of the children that were the subjects of the study, but to create a controlled research environment focusing on abatement of lead dust.

The success of the various abatement procedures would be measured, in significant part, not by reducing the levels of lead in the children's blood, but by periodic measurements of the level of lead in their blood. Thus, it reasonably can be argued that it was not in KKI's interest for the children to leave the experiment prior to its conclusion.

The record is therefore not extensive. These were the maximum allowable levels or "clearance standards" that the Maryland Department of the Environment MDE had said must be met following full lead dust abatements. We note that these "clearance standards" only apply to fully abated houses wherein all the lead dust has been removed, not to houses, which have not been abated and still have lead dust present, as is the case in Groups 1, 2, and 3 discussed, infra.

Additionally, the parties disagree as we discuss, infra notes 26 and 28, as to the appropriate method for obtaining and analyzing accurately such dust samples. Maryland Code , Repl. See Maryland Code , Repl. The same requirements controlled selection of Group 4 except that those properties had allegedly been fully abated. Assignment was based on whether the property was currently being used as a residence.

The result was an equal distribution of houses into each of the three groups. KKI contends in its briefs to this Court that appellant's residence had already been completely abated as of October 15, , and was not to be subjected to repairs and maintenance because it was a member of one of the control groups, Group 4. The evidence suggests and the parties appeared to agree during oral argument before this Court that the Monroe Street property was a member of Group 4.

Regardless, because we are reviewing this matter in the context of the granting of summary judgment based upon a trial court determination that no duty existed as a matter of law and, on remand, the facts of each case will, of necessity, need to be addressed, we do not need to resolve to which group it was a member or whether there was, as a matter of fact, a breach of duty in that case, or even damages for that matter.

Hughes of the dust sample results via letters dated December 16, , December 17, , May 19, , October 28, , July 19, , and January 18, , respectively. As we discussed, supra, appellant moved out of the Monroe Street property in the Summer of , after the first three dust samples were both collected, and the results presented, to Ms. See generally Jones v. Mid-Atlantic Funding Co.

At the time Ericka Grimes was tested for lead poisoning, the CDC used the following nomenclature to classify blood lead concentrations in children:. Polakoff, a landlord, or a landlord's representative, testified in deposition about the properties that KKI recruited into the program:. I voluntarily put this property into After that [partial abatement], a tenant with In an affidavit, Mr. Polokoff stated that KKI "would refer parents with young children to the Property.

The property was vacant and had already received the level of lead dust abatement specified by the research protocols. In other words Ms. Higgens was being recruited into moving her child into a study site that was, intentionally, not completely abated. Apparently, KKI used two different dust collecting methods, which resulted in drastically varied results.

The results discussed above were obtained from dust samples collected by an experimental Cyclone vacuum dust collector. These samples all gave results, which indicated that the lead present therein was far above the accepted Maryland clearance levels. See, supra, note However, according to KKI, the clearance levels are based on dust wipe collection not Cyclone collection. KKI presented evidence that additional samples were collected by the dust wipe technique and that these samples indicated a presence of lead below the Maryland clearance levels.

Thus, KKI argues that there was no indication of a lead hazard in the Federal Street property and thus no duty to inform appellant of the Cyclone samples.

But, in a prior related document, a May 18, , renewal request for the study, KKI included the following renewal justification: "Prior to the start of the main study, we conducted a study of side-by-side dust samples collected by the Kennedy Institute's traditional wipe method and by the HVS3 cyclone device selected for use in the main study.

We found that the HVS3 samples had higher lead loadings than the wipes for all surface types, As suggested at oral argument by KKI's representative, KKI's position is that lesser levels of lead do not constitute a hazard, even if they constitute a risk.

The argument ignores the possibility of accumulation of lead in the blood of the children from various sources. Higgins of the high lead concentration results obtained from dust samples collected by the Cyclone vacuum dust collector. KKI argues that the Maryland clearance levels for lead concentration in dust are based solely on the dust wipe collection technique and not the Cyclone vacuum testing.

Thus, because the Cyclone technique typically gives higher results, and because the dust wipe samples registered under the clearance levels, KKI argues that there was no potential hazard and thus no duty to inform appellants.

We have addressed this argument, supra, in footnote Moreover, which process is appropriate, or whether both are, is in dispute. It is thus a matter to be resolved, if necessary, on remand. Higgins beginning her tenancy at the Federal Street property, Polakoff transferred ownership of the property to CFOD-2, a limited partnership in which Chase was a general partner. In respect to the two cases, the following exchanges occurred:. Children do ingest lead through dust.

But there's nothing in the record about how much is dangerous. Respondent: I agree, and that was the purpose of this study was to try to eliminate that hazard. But in terms of defining what that hazard is, the State has done so in statute and regulation So why then should Kennedy have to have a higher duty than the landlord? The Court: Because you were testing for something the landlord was not obliged to abate, namely dust. The Court The consent form apparently said that Kennedy promised to test appellant's home for lead, discuss the results with her mother, discuss steps that could be taken to reduce risks So how is that keyed to blood levels?

My question is If they're going to test the home for lead there's an agreement to discuss the results with the mother and if you find it in the dust isn't there an obligation to discuss that with the mother irrespective of whether there's any elevated blood levels? Respondent: The plaintiff in this case alleges that there was a lead hazard in the home that needed to be discussed. And there was no hazard in the home. Kennedy did say that they were going to inform the parents of the result of the dust tests.

No indication as to when; if that would be during the study or afterwards. The Court: You don't think that a participant in the study, when an institute like Krieger comes in and says that I'm going to tell you, doesn't have a right to rely on that representation and believe that they're going to be told of that in a timely fashion, which would mean not at the end of the study but when it's determined?

Respondent: I think the expectation would be that they would be told if there were any problems. And in this case Respondent: There was no standard at the time for what constitutes a hazard with respect to lead dust in homes. The Court: But Kennedy Krieger considered the hot spot levels, The Court: How is it in their best interest then not to advise the parent until 9 months after these tests were taken?

So the only benefit to the parent was the remuneration that was given for entering into this informed consent and allowing their children to be a part of this study? The Respondent: It sounds like Your Honor is looking at this informed consent as a contract where each side is getting something out of this. And that's not the case. The informed consent is just that. It's Kennedy informing the participant what it intends to do. The Respondent: There was some remuneration involved as an incentive to get the participants to enroll and continue to follow through.

The Court: Kennedy had a reason not to tell these parents that their kids were exposed to something dangerous, because if they did the parents might leave and the kids wouldn't stay in the study to be studied down the road. That's sort of what bothers me an awful lot. If you inform the participants in the study that a danger has arisen, the participants leave the house and they're no longer in the study and the study gets skewered.

And it very specifically says in the consent agreement that they're going to test for lead dust They assert that you didn't do it. That may very well be a factual matter, If there's a dispute of material facts, I don't know how you win on a motion for summary judgment.

The Respondent They were all told within the time frame of the study itself Kennedy did nothing to hold back information to keep people in the study. They clearly told everybody if there was some lead in their dust during the study The Court: When you talk about during the study you're talking about the last day, that includes the last day of the study, which is twenty-four months down the line.

The Court: Under your theory, if the study went on for ten years, it would be O. The Respondent: If the participant had no reason to expect that the results would be forthcoming sooner. The Court: So your position is the duty would not arise unless the level of the lead in the dust exceeded the level established by some other standard that wasn't reached here? The Court: Your contract was to protect her against a risk Why wasn't that [hot spots] enough to require a warning?

Are you saying that there's a difference in the words hazard and risk? The Court: You didn't get summary judgment on the ground there was insufficient allegation of a hazard.

The Court: [It was granted because] there's no contract, no privity, no duty whatsoever, I just can't square that with your argument here. The Court: First of all, he found that there was no contract He found that there was no governmental statute or regulation, which set up this duty. He found that also didn't he? He also found no special relationship. Respondent: Kennedy needed the participants to stay in the study the full time or the results just weren't valid The Court: Suppose instead of these folks being given five dollars and fifteen dollars, Would you still argue this wasn't a contract?

Respondent: Yes. Because either side could withdraw without any claim for breach of contract from the other. The Court: You can terminate the contract unilaterally. That doesn't mean that there isn't a contract prior to that point Respondent: To say that the appellant in this case did not get any benefit from the study is pretty disingenuous.

What the appellant had the benefit of in this study of [was] being able to live in a home that had these repairs done to it The Court: A child that has no lead paint, that is normal, moves into a house that has been partially abated and ends up with elevated lead paint levels and you say that's a benefit? Respondent: We don't know what this child's lead levels were before moving into this home, nor do we know where this child was poisoned.

Respondent: Because that was the only way to measure if the children did get poisoned as well as Respondent: No, and this is why it doesn't bother me. Because these homes were in disrepair. Kennedy went in there and improved the home and in this case the home was improved so that it was below clearance standard The Court: But that almost assumes that they realize that some of the partial abatements would not be successful.

How can you deny that? Respondent: What they expected was that different levels of repair would have different levels of effectiveness over time.

And that's what they were testing. The Court: To see which abatement they could use most cheaply? To try and abate more properties in Baltimore City. Respondent: Yeah. I don't disagree with that. And all of that was for the benefit of society at large and these children. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision.

This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment.

The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.

The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. No experiment should be conducted where there is a prior reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects.

The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.

Proper preparations should be made and adequate facilities provided to protect the experimental subject against even the remote possibilities of injury, disability, or death. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.

During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seemed to him to be impossible. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgement required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

The particular experiment was conducted by American scientists, and was discontinued, and then concealed in the post-World War II period because of concerns raised by students that it was a "monster experiment" that would, if discovered, be compared to the World War II experiments and would ruin the careers of the scientists and researchers involved.

Wendell Johnson was a stutterer. As his education and career advanced, he formulated hypotheses that stuttering is emphasized and conditioned in children by environmental causes rather than by genetic or inherited traits. He believed that criticism by parents, and others, during childhood years, caused children to lose confidence in their ability to communicate by speech, resulting, in the worst cases, in stuttering.

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Then, MHA proclaimed sport titles about risk utilizing multimedia presents will come to be allowed. While Joe was alternating years as a professor of linguistics at Cornell University, and running discourse workshops for SIL in Brazil, New Guinea, Philippines, Nepal, Nigeria, Ghana, and other places, Barbara kept busy systematically refining the information in the Ethnologue for those and other countries around the world—much of it before the age of email.

She also co-lectured at workshops on sociolinguistic surveys in Colombia , Philippines , Indonesia , Malaysia , and Kenya Her three children were born and raised in Mexico, and Barbara home schooled each of them at various stages of their education.

Marilyn died in from breast cancer. Joe and Barbara also have 7 grandchildren and 10 great-grandchildren living in three countries. People describe Barbara with words like: meticulous, tenacious, faithful, loyal, humble, and big picture visionary. She was also a beautiful woman. She still looks as beautiful as she did at Wheaton. Member Field investigator, Huichol language project, Mexico , , Field investigator, Hawaii Pidgin language project, Instructor in Linguistics, Summer Institute of Linguistics summers University of Oklahoma , , , , University of North Dakota , , University of Texas, Arlington Editor, Ethnologue: Languages of the World Assistant Editor Editorial Assistant , Education: Litt.

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Dallas: Wycliffe Bible Translators. Editor , , Joseph E. Grimes and Barbara F. Ethnologue Language Family Index. Notes on Linguistics, Special Publication No.