Ethics and Design of a Human Challenge Study

Identify permissions, ethical stakes, and how the experiment was built

This activity uses the same paper from the human challenge study: healthy young adults were deliberately infected with SARS-CoV-2 under medical supervision so researchers could watch an infection unfold from the very first hour. You already practiced reading a primary paper in activity 3. Here the goal is different — to identify what had to be approved, what ethical issues the study raises, and how the experiment was designed.

You will read it in the same annotating PDF viewer. When you select text, a note panel opens and you can leave a comment that the rest of the class can see and reply to.

NoteWhat you are being asked to do
  1. Annotate at least two ethical issues or permission/oversight requirements you find in the paper. Look for language about consent, risk, isolation, who could enroll, ethics board review, or other safeguards. Name the specific passage and explain why it matters.
  2. Annotate at least three experimental-design choices the authors made. Examples include the challenge dose or route, inclusion and exclusion criteria, endpoints, monitoring schedule, controls or comparisons, and how outcomes were measured.
  3. Reply to at least one classmate on either ethics or design. Build on their note or offer a different reading of the same passage.

Be specific about what you are pointing to in the paper. A vague note like “this seems risky” is less useful than naming the risk, who bears it, and what the authors say about managing it.

Before you start

You should already have a Hypothesis account and be in the BILD 5 class group from activity 3. If not:

  1. Create an account at hypothes.is/signup.
  2. Join the class group using the invite link posted in Canvas.
  3. Open the reading below and sign in using the panel on the right.
ImportantCheck the group selector before you annotate

At the top of the annotation panel there is a dropdown that controls who sees your note. It should read BILD 5.

If it reads Public, switch it to BILD 5 before you post — Public means the whole internet can read it. If you post to Public by mistake, delete the annotation and post it again in the group.

The reading

Open the paper and annotate it

Opens in a new tab. Give it a moment on first load: it is a large file.

If the annotation panel does not appear, or you cannot get signed in, you can still read the paper on its own: download the plain PDF. Bring your notes to class and we will get the tool working with you.

Citation

Killingley, B., Mann, A.J., Kalinova, M. et al. Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults. Nature Medicine 28, 1031–1041 (2022). https://doi.org/10.1038/s41591-022-01780-9

Published open access under a Creative Commons Attribution licence.