Discussion Post Responses
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Please respond back to all 3 discussion posts. Each response must be at least 2 paragraphs with at least 2 references.
- Why is 45 CFR 46 called the “Common Rule”? Identify and explain two (2) reasons.
- What is the difference between the two titles – in other words, why do we have 2 sets of regulations? Have changes in the revised Common Rule requirements impacted the differences in the regulations? If so, how?
The common Rule states the regulations to follow to protect research subjects in clinical research. According to Office for Human Research Protections (2021), “Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects” (p. 1). The reason behind the name “Common Rule” has to do with a set of ethical rules that are used to for human research protection. These common rules must be followed by the IRB to ensure proper research. As Mazur (2007) mentions, “…an institution must establish and delegate to an IRB the authority to review, stipulate changes in, approve or disapprove, and oversee human subject protections for all research conducted in that institution.” (Mazur 2007) The IRB must review each research site and ensure that the 45 CFR 46 is being proposed and followed.
The common rule is in place for Department of Health and Human Services basic rules in protection of human subjects in research and 21 CFR 50 includes the Food and Drug Administration’s Code of Federal Regulations. The main difference between both titles is the federal agencies that administer these rules. According to ProPharma Group (2018), “In 1991, FDA amended its regulations to conform with the Common Rule (with a few exceptions due to differences in FDA’s mission or statute)” (p 1). There was a revised common rule (“2018 Requirements”) which created differences between FDA & HHS human subject regulations. Research sites are to comply with both regulations to be approved by the IRB. There have been some changes in the revised common rules, some of these include general requirements to the informed consent, requirements to the continuing review and exemptions.
Human subject protection regulations: Differences between HHS’ & FDA’s clinical trial rules. ProPharma Group. (2021, July 8). Retrieved August 19, 2022, from https://www.propharmagroup.com/blog/hhs-fda-human-…
Mazur, Dennis J., (2007) Evaluating the Science and Ethics of Research on Humans: A guide for IRB members
Office for Human Research Protections (OHRP). (2022, January 7). 45 CFR 46. HHS.gov. Retrieved August 19, 2022, from https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#:~:text=Subpart%20A%2C%20also%20known%20as,provides%20requirements%20for%20IRB%20registration.
The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government (Health, 2018). Both federal agencies the Department of Health and Human Services HHS and FDA oversight and regulate human research. Thus each of them adopted regulations and guidelines to govern the protection of human subjects in research.
HHS basic regulations coded 45 CFR 46 Protection of Human Subjects (Common Rule) (Protections (OHRP), 2016). The regulations are based on the Belmont Report and were written to offer basic protections to human subjects involved in both biomedical and behavioral research conducted or supported by HHS. It’s called the Common Rule because it has been adopted by several federal departments and agencies. Additionally, it promotes uniformity, understanding, and compliance with human subject protections and creates a uniform body of regulations across federal departments and agencies (Human Subject Protection Regulations, 2018). 45 CFR 46 comprises additional protections for pregnant women, human fetuses and neonates, prisoners, and children, (Common Rule | Human Research Protection Program | Michigan State University, n.d.; Protections (OHRP), 2017).
FDA regulations for human subject protection are coded in 21 CFR 50 as Protection of Human Subjects title. (CFR – Code of Federal Regulations Title 21, n.d.; Commissioner, 2022). In 1991, FDA amended its regulations to conform with the Common Rule. However, the regulations are not always consistent with one another. Differences in the rules are due to differences in the scope of each agency or its requirements. As stated by the authors (Pfeiffer & Wells, 2017), the FDA focuses on the marketing approval of medical products while protecting the participants as well in the research. But the OHRP oversees research conducted or sponsored by government agencies or departments that have adopted the Common Rule. Thus having two sets of regulations is necessary. Examples of the differences are that HHS has special subparts relating to vulnerable populations, e.g., children, prisoners, and pregnant women while FDA does not have comparable provisions for these populations but it has additional IRB requirements. HHS regulations require assurances and certifications from the grantee institution. FDA regulations require assurances of compliance from the research sponsor and the clinical investigator (Commissioner, 2018).
Yes, changes in the revised Common Rule requirements impact the differences in the regulations. The availability of a uniform, clear set of regulations would be helpful, easy to understand and follow and reduce conflict or misinterpretation. Both regulations serve the main purpose that is protecting the health and welfare of the research participants and some clinical trials might fall under the regulations of both agencies. So, harmonizing differences in the regulations by the changes in the revised Common Rule would be necessary and beneficial too. In the issued guidance released by FDA, it was stated that “the FDA intends to undertake notice and comment rulemaking to harmonize, to the extent applicable, FDA’s regulations with the revised Common Rule” (Commissioner, 2019).
CFR – Code of Federal Regulations Title 21. (n.d.). Retrieved August 20, 2022, from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs…
Commissioner, O. of the. (2018). Comparison of FDA and HHS Human Subject Protection Regulations. FDA. https://www.fda.gov/science-research/good-clinical…
Commissioner, O. of the. (2019, July 18). Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations. U.S. Food and Drug Administration; FDA. https://www.fda.gov/regulatory-information/search-…
Commissioner, O. of the. (2022, August 18). U.S. Food and Drug Administration. FDA; FDA. https://www.fda.gov/home
Common Rule | Human Research Protection Program | Michigan State University. (n.d.). Retrieved August 20, 2022, from https://hrpp.msu.edu/help/overview/hhs.html
Health, C. for D. and R. (2018). Code of Federal Regulations—Title 21—Food and Drugs. FDA. https://www.fda.gov/medical-devices/medical-device…
Human Subject Protection Regulations: Differences Between HHS’ & FDA’s Clinical Trial Rules. (2018, October 22). ProPharma Group. https://www.propharmagroup.com/blog/hhs-fda-human-…
Pfeiffer, J., & Wells, C. (2017). A Practical Guide to Managing Clinical Trials. CRC Press.
Protections (OHRP), O. for H. R. (2016, February 16). 45 CFR 46 [Text]. HHS.Gov. https://www.hhs.gov/ohrp/regulations-and-policy/re…
Protections (OHRP), O. for H. R. (2017, March 7). 2018 Requirements (2018 Common Rule) [Text]. HHS.Gov. https://www.hhs.gov/ohrp/regulations-and-policy/re…
45 CFR 46 is called the “Common Rule” because, “title 45, part 46 is known as the “protection of human subjects”, and subpart A of this title, is referred to as “the Common Rule,” which regulates the conduct and support of this type of research” (Mazur, 2007, p. 13). The Common Rule consists of regulations in which are set in place to protect human subjects in clinical research (https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html (Links to an external site.)).
There are multiple regulations set in place to protect research whether it be the design of a medical device or an active research site that involves human subjects. The main difference between the “Common Rule” and Title 21 CFR 50 is that, the common rule is mainly focused on protecting human research subject in research and Title 21 CFR 50 while administered through the FDA, and covers food and drug regulations, it also extends the protection when involving human subjects in research.
Mazur. (2007). Evaluating the science and ethics of research on humans : a guide for IRB members. Johns Hopkins University Press.