Final answer:
The FDA mandates that informed consent for research should include descriptions of all risks and benefits, even if there is no expected benefit. Informed consent involves clear communication about the study's implications, ensuring voluntariness, preserving confidentiality, conducting a fair subject selection, assessing risks involved, and considering societal value of the research.
Step-by-step explanation:
Yes, the FDA does require that consent forms for research trials include a description even if the research provides no expected benefit. All risks and benefits must be clearly outlined to participants. This ensures that study participants can give informed consent, which is a fundamental ethical requirement in clinical research. Participants must be informed of relevant aspects of the study, including any foreseeable risks, voluntary nature, confidentiality stipulations, equitable selection of subjects, and the potential impact of the research on society.
Potential violations of the rule requiring informed consent include:
- Inmates in a correctional facility being offered good behavior credit in exchange for participation without fully understanding the research implications.
- Conducting a study to investigate a new children's allergy medication without parents or guardians' proper consent.
- Telling participants that a new medication is highly promising without disclosing that some will receive placebos.