Questions: A waiver of the requirement for documentation of informed consent may be granted when: - The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. - The investigator has no convenient place to store signed consent forms separate from the research data. - Potential subjects might find some of the research questions embarrassing, personal, or intrusive. - The subjects are literate in their own language; however, they do not read, write, or speak English.

The answer is the first one: "The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality."

Explanation for each option:

1. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

   • This is correct. According to federal regulations and ethical guidelines, a waiver of documentation of informed consent can be granted if the only record linking the subject to the research is the consent document itself, and the main risk involves a breach of confidentiality. This is to protect the privacy of the participants.

2. The investigator has no convenient place to store signed consent forms separate from the research data.

   • This is incorrect. The convenience of the investigator is not a valid reason for waiving the requirement for documentation of informed consent. Ethical guidelines prioritize the protection of participants over logistical issues faced by researchers.

3. Potential subjects might find some of the research questions embarrassing, personal, or intrusive.

   • This is incorrect. While the nature of the questions might require careful handling and sensitivity, it does not justify waiving the documentation of informed consent. Researchers must still obtain informed consent, possibly through alternative methods that ensure participants are fully aware of the study's nature and their rights.

4. The subjects are literate in their own language; however, they do not read, write, or speak English.

   • This is incorrect. Language barriers do not justify waiving the documentation of informed consent. Instead, researchers should provide consent forms in the participants' native language or use interpreters to ensure that participants fully understand the consent process.

In summary, the correct condition for waiving the requirement for documentation of informed consent is when the only record linking the subject and the research is the consent document, and the principal risk is a breach of confidentiality.