Final answer:
The informed consent in research must include information on the risks associated with participation, ensuring that this consent is based on a clear understanding of these risks. Participation must be voluntary, and privacy must be safeguarded. The IRB oversees these aspects to maintain ethical and legal standards in research.
Step-by-step explanation:
The informed consent in research must include various elements to ensure that participants are fully aware of what their participation involves. The correct answer to what must be included in the informed consent is Participants must be informed of risks associated with participation. This is fundamental, as participants have the right to know all the potential risks and benefits associated with the study before agreeing to take part. Additionally, they must be informed that their participation is voluntary and that they may withdraw at any time without penalty.
It is also essential to maintain the privacy and confidentiality of participants' data. While participants might not need to know the specific funding source for the research, it is crucial that they are aware of how data collected from them will be used in the future. This may include whether the data will be archived for future use, destroyed at the end of the project, or potentially used in publications or research databases. Moreover, participants' consent is required to be in writing, and researchers must keep documentation of this consent.
The idea of informed consent is not just an ethical requirement but also a legal one, overseen by the Department of Health and Human Services and regulated by Institutional Review Boards (IRB). Whether it's sociocultural, medical, or clinical studies, transparency with participants about the intent and implications of research is paramount.