A study coordinator is developing an informed consent form for the first time.

Theinformed consent processmust include all basic elements listed in federal regulations.

21 CFR 50.25(a)(4):Requires “a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.”

ICH E6(R2) 4.8.10(c):Mirrors this, requiring subjects to be informed of alternatives to participation, including available standard treatments.

This ensures the ethical principle ofRespect for Persons(Belmont Report), giving subjects the autonomy to choose among reasonable medical options.

Incorrect options:

A: Contact information must be provided, but it is for the investigator (or IRB), not sponsor.

B: Financial disclosures may be required for IRB review, not subject-facing.

C: Subjects do receive a copy, but it is not a required consentelementin regulations.

Correct answer:D.