For an investigational new drug study that has potential side effects of myalgia, arthralgia, and lethargy, which of the following could serve as an…

The fundamental principle of informed consent is that information must be presented in a language that is understandable to the research participant. Option B effectively translates the technical medical terms "myalgia," "arthralgia," and "lethargy" into plain, everyday language: "muscle aches," "joint pain," and "tiredness." This ensures the potential subject can clearly comprehend the reasonably foreseeable risks associated with the investigational drug, allowing them to make a truly informed decision, as mandated by federal regulations and international guidelines.

A. You might experience adverse events of myalgia, arthralgia, and lethargy

This option uses technical medical jargon ("myalgia," "arthralgia") and clinical trial terminology ("adverse events") that a layperson is unlikely to understand.

C. You might develop symptoms of myalgia, arthralgia, and tiredness

This statement is a mix of technical and plain language, which can still be confusing and does not meet the goal of being fully understandable.

D. You might have some mild side effects while taking the investigational drug

This statement is too vague. It fails to describe the specific, reasonably foreseeable risks, which is a required element of informed consent.

1. U.S. Food and Drug Administration (FDA). Code of Federal Regulations Title 21, Part 50.20 (21 CFR 50.20) - General requirements for informed consent. This regulation states, "...the information that is given to the subject or the representative shall be in language understandable to the subject or the representative."

2. U.S. Department of Health & Human Services (HHS). Code of Federal Regulations Title 45, Part 46.116(a)(3) (45 CFR 46.116) - General requirements for informed consent. This regulation requires that the information "be in language understandable to the subject... The prospective subject... must be provided with the information that a reasonable person would want to have in order to make an informed decision..."

3. International Council for Harmonisation (ICH). Guideline for Good Clinical Practice E6(R2), Section 4.8.6. This guideline specifies, "The language used in the oral and written information about the trial, including the written informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness, if applicable."

4. University of Michigan Medical School Institutional Review Board (IRBMED). In its guidance on "Writing a Consent Form," the IRB provides a "Plain Language Medical Dictionary" which explicitly recommends translating "Arthralgia" to "Joint pain" and "Myalgia" to "Muscle pain" to improve readability for participants. (Available on the University of Michigan's official IRB website).