Ethics – Human Case Study (2009) - Red Bull

Mon, 2012-02-27 10:54 -- pwhippey

Description of the Project

Our Ethics/Safety Committee is grappling with an approval application. The student wants to assess the heart rates of 4 participants (adults) before, during and after 20 minutes of treadmill exercise. There will be3 trials: 1 with no caffeine, one with Red Bull, and one with coffee. Although these are adults, who normally consume coffee, the committee hesitates to approve this project. They would like an outside opinion.

Advice or Ruling

This project involves asking human participants to take a drug - caffeine - and the energy drink Red Bull.

Section 3.4 of Policy 4.1.1.2 Participation of Humans in Research - Significant Risk gives the rules for Ingestion projects:
3.4 Ingestion Projects

  1. Some provinces have put in place rules that govern ingestion of food by the public, and these take precedence over the rules in this section. Students doing ingestion projects must know the applicable procedures required for the safe handling of food.
  2. Projects involving ingestion of food or drink, defined as consumption through eating or drinking, are considered Significant Risk when they involve:
    1. articles not manufactured, sold or represented as food or drink for human beings;
    2. foods that contain additives exceeding the Recommended Daily Intake (RDI) normally associated with those foods;
    3. foods not considered to be basic or everyday foods and for which health benefits are claimed.
  3. Projects involving ingestion of licensed Natural Health Products and Energy Drinks are not permitted at the Canada Wide Science Fair or similar YSC events. These products are identified by a Health Canada Natural Product Number NPN) or Exemption Number (EN), and are listed in the Health Canada Natural Health Product Database.3
  4. Projects that involve the consumption of alcohol are not permitted at the Canada Wide Science Fair or similar YSC events.
  5. Significant Risk Ingestion projects are allowed only if carried out under professional supervision at a laboratory with its own internal Ethics Review Committee, such as a university or hospital laboratory.

Thus the decision of the Ethics Committee is that this project is not eligible for entry into a science fair.

We know that this will be a disappointment, and that the student involved has invested considerable enthusiasm in it. We do hope that this energy and enthusiasm can be directed to another topic, that does not involve the use of drugs, as defined by Health Canada, outside a licensed laboratory.

Update:

SInce this ruling was issued in 2009, Health Canada has changed its position on Energy Drinks, issuing this bulletin on 6 October 2011:

The National Ethics Committee reviews the issues associated with ingestion projects regularly to ensure that the rules at the CWSF reflect best practises and the latest research findings.

Your Project

If your proposed science fair project involves the participation of humans or the use of animals,
  1. Visit the Ethics web page so as to become familiar with the policies.
  2. Fill in the Request for Advice or a Ruling.
  3. Submit it to the Ethics Committee of your Regional Science Fair.

Disclaimer

These case studies summarize interesting examples of science fair projects involving humans or animals submitted to the Youth Science Canada National Ethics Committee for review. A brief description of the proposed project is given, along with the ruling given by the Ethics Committee. Some details may have been changed in the descriptions so that the original source cannot be identified. The ethical challenges described have not been changed.

science