Podcast
Questions and Answers
A researcher is conducting a study involving human subjects. Which subpart of the HHS regulations, specifically, outlines the general protections applicable to all research participants?
A researcher is conducting a study involving human subjects. Which subpart of the HHS regulations, specifically, outlines the general protections applicable to all research participants?
- Subpart E
- Subpart C
- Subpart A (correct)
- Subpart B
A research institution decides to transition a study, initially started in 2017, to comply with the revised Common Rule. What is the primary implication of this decision regarding the study's adherence to ethical guidelines?
A research institution decides to transition a study, initially started in 2017, to comply with the revised Common Rule. What is the primary implication of this decision regarding the study's adherence to ethical guidelines?
- The study can choose between the pre-2018 and 2018 requirements at any point.
- The study immediately falls under the 2018 Requirements. (correct)
- The study must adhere to the pre-2018 Common Rule for its duration.
- The study is exempt from all ethical guidelines.
A university's IRB is registering with the federal government. Which subpart of the HHS regulations provides requirements for this registration?
A university's IRB is registering with the federal government. Which subpart of the HHS regulations provides requirements for this registration?
- Subpart B
- Subpart A
- Subpart E (correct)
- Subpart D
A researcher needs to share sensitive data collected during a study. What is the most secure way to share this information online?
A researcher needs to share sensitive data collected during a study. What is the most secure way to share this information online?
A research study focuses on vulnerable children. Besides the Common Rule, which additional HHS subpart would provide extra protections for these participants?
A research study focuses on vulnerable children. Besides the Common Rule, which additional HHS subpart would provide extra protections for these participants?
Flashcards
.gov Websites
.gov Websites
Indicates an official government organization website in the United States.
HTTPS (Secure Connection)
HTTPS (Secure Connection)
Indicates a secure connection to a website, ensuring safer data transmission.
45 CFR 46
45 CFR 46
A U.S. regulation outlining human subject protection in research.
Common Rule (Subpart A)
Common Rule (Subpart A)
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Subparts B, C, and D
Subparts B, C, and D
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Study Notes
- Official US government websites use ".gov"
- ".gov" indicates an official government organization
- Secure ".gov" websites utilize HTTPS for safe connections
- A lock icon or "https://" signifies a secure connection to the ".gov" website
- Sensitive information should only be shared on official, secure websites
- The HHS regulations at 45 CFR 46 protect human research subjects, comprising five subparts
- Subpart A, or the Common Rule, offers strong protections for research subjects
- The Common Rule, subpart A, underwent revisions in recent years known as the "2018 Requirements"
- Subparts B, C, and D offer extra safeguards for specific research populations
- Subpart E details requirements for institutional review board registration
- Research started before January 21, 2019, typically follows the pre-2018 Common Rule
- Institutions had the option to transition research to the revised Common Rule
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Description
Learn about the significance of .gov domains for official US government websites and secure online interactions. Understand HHS regulations at 45 CFR 46, which protect human research subjects, including the Common Rule and its 2018 revisions. Explore subparts offering safeguards for specific populations and IRB registration.
