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Book

Human Subjects Research Design

Marlon L. Bayot  1 , Grace D. Brannan  2 , Janelle M. Brannan  3 , Steven Tenny  4
In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan.
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Book

Human Subjects Research Design

Marlon L. Bayot et al.
Free Books & Documents

Excerpt

Human subjects research is a heavily regulated type of research, hence this paper will start with two critical definitions. The US Department of Health and Human Services (HHS) Code of Federal Regulations, 45 CFR 46, provides the following definitions: “A living individual about whom an investigator (whether professional or student) conducting research:

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Conflict of interest statement

Disclosure: Marlon Bayot declares no relevant financial relationships with ineligible companies.

Disclosure: Grace Brannan declares no relevant financial relationships with ineligible companies.

Disclosure: Janelle Brannan declares no relevant financial relationships with ineligible companies.

Disclosure: Steven Tenny declares no relevant financial relationships with ineligible companies.

References

    1. Bass PF, Maloy JW. How to Determine if a Project Is Human Subjects Research, a Quality Improvement Project, or Both. Ochsner J. 2020 Spring;20(1):56-61. - PMC - PubMed
    1. Röhrig B, du Prel JB, Wachtlin D, Blettner M. Types of study in medical research: part 3 of a series on evaluation of scientific publications. Dtsch Arztebl Int. 2009 Apr;106(15):262-8. - PMC - PubMed
    1. Tenny S, Brannan JM, Brannan GD. StatPearls [Internet] StatPearls Publishing; Treasure Island (FL): 2022. Sep 18, Qualitative Study. - PubMed
    1. Cleland JA. The qualitative orientation in medical education research. Korean J Med Educ. 2017 Jun;29(2):61-71. - PMC - PubMed
    1. Farrugia P, Petrisor BA, Farrokhyar F, Bhandari M. Practical tips for surgical research: Research questions, hypotheses and objectives. Can J Surg. 2010 Aug;53(4):278-81. - PMC - PubMed

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