Medical Research Cases/Consent and Informed Consent

Grimes v. Kennedy Krieger Institute, Inc., 366 Md. 29, 782 A.2d 807 (Md. 2001)

(Be sure to read the real story - - JOANNE POLLAK, J.D., THE LEAD-BASED PAINT ABATEMENT REPAIR & MAINTENANCE STUDY IN BALTIMORE: HISTORIC FRAMEWORK AND STUDY DESIGN - Published in the Journal of Health Care Law & Policy, Vol. 6, Issue 1, 2002 and used with their permission.)

Why were they concerned about the potential exposure of children to environmental lead?

What was done to the experimental houses?

How should this affect the risk of lead exposure as compared to houses that were not part of the experiment?

Are there children living in the houses that were not part of the experiment?

What should happen to risk to those children who move into the experimental houses?

What is the canary in the mine example the court uses?

Is this really what was happening in the experiment?

What does this tell you about the majority's views of the case?

What is non-therapeutic research?

Why is it so controversial for children?

Who has to consent?

Was Mr. Stewart in the Cleveland Clinic case participating in therapeutic or non-therapeutic research?

Was it really therapeutic for him, when you look at the arm of the trial he ended up in?

What was the control group?

Why did the institution not want to call them a control group?

What did it suggest instead?

Does this characterization change the risks?

What was the crux of the court's objections - paragraph 21?

Where would these children be if there was no experiment?

Would they be a great or reduced risk of lead exposure?

Why did the court say that the could not be trusted to consent for their children?

What is a "for the greater good" project?

What about the research in Cleveland Clinic case?

Who benefited from Mr. Stewart not getting chemotherapy?

What did Justice Brandis have to say?

What studies did the court compare this too?

Is this really equivalent to the Tuskegee Syphilis Study or the Japanese plague bomb, or the experiments in the Nazi death camps?

What is the purpose of this rhetoric?

Where did the court have to go to find a United States Supreme Court comment about the what it sees as the problems with IRBs?

What are the specific allegations in the cases - paragraph 37?

What was the ruling of the trial court?

How does this ruling prevent the plaintiff's from stating a prima facie case?

Where did the trial court look for a legal duty?

Skip down to Paragraph 118 and analyze what the court says about legal duty.

Is this a reasonable reading?

Would this also be the case in LA?

Is the Nuremberg code US law?

What has to happen before something like this becomes US law, either at the state or federal level?

Why is the court citing it?

How does the court use the consent form to create a legal duty? (Para 161)

What is the problem with the consent form as regards the risks of the experiment?

What was the problem with reporting the results of lead blood tests to the parents?

What is the federal standard for informed consent?

What did the court say about the ethical appropriateness of the research - paragraph 202?

Do you agree or disagree?

What did the court say about appropriateness of parental consent to non-therapeutic research?

What does it require as an alternative? (256)

How feasible would this be for this experiment?

What does the concurrence by Raker say is the real issue in this case? (264)

Why does Raker concur in the judgment?

Does he agree with the rest of the court's opinion?

What is his criticism of the opinion?

What do you think will be the effect of this decision on the study of lead abatement?

Will this make children better off than if the study is able to be done?