Dr Tom Kerns
North Seattle Community College


Assignment for Week Seven


Your assignment this week will be to take on the character of a Human Subjects Review Committee (HSRC), deliberate about three biomedical human subjects experiments, and decide whether you will approve them to be done or not.

You will be divided into two groups, each group will deliberate separately about the experiments, come to a conclusion about each experiment, and issue a report to the class on each of its three decisions.

All three of these experiments you will be examining are real experiments that have actually been done in the past or are being done now. (Of course, as we know from the Tuskegee Study, just because a study has been done doesn't mean it should have been done.) For each proposed experiment your committee can make one of three determinations:

1. Approve the study as it is presented.

2. Approve the study but only with certain conditions (list the conditions, and explain why they are necessary).

3. Reject the study.

The first experiment about which you will deliberate is Edward Jenner’s famous smallpox vaccine experiment in 1796, about which there has been much debate and discussion.

The second and third experiments are current studies regarding the health effects of pesticide exposure on fetuses, infants, and young children.


All the required readings this week are available online, via links from the Online Texts Homepage:

  • Kerns, Jenner On Trial: The Ethics of Vaccine Research in the Age of Smallpox and the Age of AIDS (Preface, Introduction, Chapters 1-4 only)
  • Edward Jenner’s Ethics Review Committee Application Form
  • Edward Jenner’s Consent Form
  • Berkowitz, Obel, et al, “Exposure to Indoor Pesticides during Pregnancy in a Multiethnic, Urban Cohort”
  • Elgethun, Fenske, et al, “Time–Location Analysis for Exposure Assessment Studies of Children Using a Novel Global Positioning System Instrument”
  • WHO/CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects
  • The Universal Declaration of Human Rights

Your Charge:

I. Your first job as an HSRC will be to review what your ethical standards will be for evaluating all these proposed trials. To do this you will 1) Review the Nuremberg Code, 2) read the WHO/CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, 3) read the Universal Declaration of Human Rights (UDHR), and 4) Review the Belmont Report.

These documents may require some discussion in your group to make sure you understand the major provisions.

II. Your second charge, to be begun at least by Friday, will be to discuss the merits of Edward Jenner’s proposed smallpox vaccine experiment. Your primary sources of information for this will be 1) Kerns, Jenner On Trial (for informational background about smallpox, Jenner, the experiment itself, etc), 2) Jenner’s Ethics Committee Application Form, and 3) Jenner’s Informed Consent Form.

Your Committee will need to come to its decision about this trial by Saturday night or Sunday morning so that a report can be written and issued to the classroom by Sunday evening.

If you finish these first two above tasks before Sunday you can go ahead and get an early start on the next task.

III. Your third charge will be to discuss the merits of the two pesticide trials. Your primary sources of information about these trials will be the two articles above, both published in Environmental Health Perspectives, a peer reviewed journal published by the National Institute of Environmental Health Sciences, one of the US National Institutes of Health (NIH). You may, if you wish, read only the short abstract at the beginning of these two studies, and the few paragraphs on “Methods.” It may be helpful to read the entire articles, but it is not required.

Your committee can begin discussing these two trials any time but the decisions will need to be made and the reports posted by Tuesday evening.

Wednesday will be for more general discussions about the trials and the ERC process.

Human Subjects Review Committee memberships:


  • Virginia
  • Gina
  • Kayleigh
  • Sara
  • Ifeanuli
  • Alexandra
  • Heather


  • Caitlin
  • Annie
  • Tae
  • Lindsay
  • Michael
  • Tammy
  • Mimi

As with previous groupings, everyone is free to read postings in the other groups/committees, but please post messages only to your own committee.