Ethics – Human Case Study (2009) - Potassium Supplements

Mon, 2012-02-27 10:47 -- pwhippey

Description of the Project

Title: Effect of Potassium on Reaction Time.

Hypothesis: I think that a potassium supplement will slightly improve reaction time. I think this because nerves use potassium for impulse transmission, so logically, increasing the intake of potassium should result in improved reaction time, particularly in individuals with inadequate potassium in their diets. The substances I plan to use are Jamieson’s 50 mg Potassium tablets and “Wake Ups” 100mg caffeine tablets for comparison.

Procedure:

  1. Have participant fill out consent form and receive ID number.
  2. Have participant fill out questionnaire then pre-test questionnaire. (to be filled out before each test.) (see attached form)
  3. Familiarize participant with computer-based reaction test. This will be a test where you click the mouse when prompted on screen. Participants should have an opportunity to play with this before the baseline tests are done so that the results aren’t affected by inexperience.
  4. Test and record baseline result.
  5. Have participant take either a 100mg caffeine tablet, a 50 mg potassium tablet or a placebo, depending on group and trial number.
  6. Repeat the reaction test three times over 20 minutes at 35, 45 and 55 minutes after taking the tablet.
  7. Record and graph results.
  8. Repeat procedure with remaining tablets on subsequent days.
  9. Analysis and conclusions.

Advice or Ruling

This project involves giving a drug - in this case caffeine - to a group of human participants. Youth Science Canada Policy 4.1.1 .2 Participation of Humans in Research - Significant Risk states in section 3.2 :

  1. Definition of a “drug”: “drug” includes any substance or mixture of substances manufactured, sold, or represented for use in:
    1. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in humans or animals,
    2. restoring, correcting, or modifying organic functions in humans beings or animals;
    3. disinfection in premises in which food is manufactured, prepared or kept.b
  2. Drugs may be used in any experiment exhibited at a Science Fair only if carried out in a Hospital, University, Medical or other similar Laboratory under the direction of a Scientific Supervisor. The study
    must be approved by the appropriate Scientific Review Committee that reviews the research at the Institution, and this must be documented by a letter that forms part of the application to the School, Regional or Canada Wide Science Fair, or any event organized by, or coming under the auspices of Youth Science Canada. No other studies involving the use of Drugs, as defined above by Federal Regulations, may be exhibited at any Science Fair or similar event.

If you visit this web site:

you will find some cautions and warnings, although at doses higher than you propose.

Thus to carry out this project, you would have to find a licensed laboratory and a mentor licensed and able to provide professional supervision, who would act as your Scientific Supervisor. If you were to find a suitable scientific supervisor, you would have to submit a much more detailed proposal. Your questionnaire needs significant work for example. You would also need to develop an Informed Consent form.

I am sorry the news is not better. We know that you have put significant work into this project to get it to this stage, and that you are excited about it.

Here is a link to sets of web pages with many ideas for projects:

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.