Reformed U.S. Common Rule and Current Trends in Human Subject Protection Policy (미국 연구대상자 보호 정책의 최신 동향 -개정된 커먼룰(Common Rule)을 중심으로-)

Junho Jung (정준호); Kim, Ock Joo (김옥주)

Reformed U.S. Common Rule and Current Trends in Human Subject Protection Policy

Journal of the Korea Bioethics Association
2017, 18(1), pp.63-82
Publisher : The Korean Bioethics Association
Research Area : Interdisciplinary Studies > Interdisciplinary Research

Junho Jung ¹, Kim, Ock Joo ²

¹서울대학교 인문의학교실
²서울대학교

Accredited

ABSTRACT

Fully revised and updated U.S. Common Rule (Federal Policy for the Protection of Human Subject) will come into effect from January 19, 2018. Updated Common Rule reflects the changes in research landscape, as well as public view of human subject research. Purpose of the revision is to modernize, strengthen, and make more effective policy. It is intended to facilitate valuable research, reduce burden, delay, and ambiguity for investigator while better protecting human subject involved in research. Changes in its scope and definitions of Common Rule suggest that Bioethics and Safety Act in Korea may also need substantial revision which can reflect the current shifts in research enterprise. This study focuses on historical development of the Common Rule, and significant changes from pre-2018 rule in the final rule (2017) of the Common Rule which shows changing concept of human research protection. This will help to understand the context of development process of Common Rule that had substantial influence on Korea’s Bioethics and Safety Act.

KEYWORDS

Human Subject Research, Human Research Protection, Common Rule, Institutional Review Board, Informed Consent, Biospecimen

Citation status

* References for papers published after 2023 are currently being built.

[journal] Levine C. / 1988 / Has AIDS changed the ethics of human subjects research? / Law Med Health Care 16(3) : 167~

[journal] 이인영 / 2013 / A Retrospective Study on History of Science and Science and Technology Laws and Bioethics Law in Korea / 생명윤리 / 한국생명윤리학회 14(1) : 65~86

[journal] 김은애 / 2014 / Significance and limitation of recent changes in the wholly amended 「Bioethics and Safety Act」for the protection of the human research participant / 생명윤리 / 한국생명윤리학회 15(2) : 15~35

[journal] Menikoff J. / 2017 / The Common Rule, Updated / N Engl J Med 376(7) : 613~615

[web] / 2017 / Federal Policy for the Protection of Human Subjects: Final Rule. Federal Register. 2017;82(12):7149-7274 / https://www.gpo.gov/fdsys/pkg/FR-2017-01-19/pdf/2017-01058.pdf

[journal] 김옥주 / 2002 / The Nuremberg Code and Ethics of Human Subject Research / 한국의료윤리학회지 / 한국의료윤리학회 5(1)

[journal] 김옥주 / 2005 / 인체를 대상으로 하는 연구윤리의 발전 / 진보평론 (12) : 40~56

[web] / Belmont Report / https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html

[journal] Miller F.G. / 2007 / Facing up to paternalism in research ethics / Hastings Cent Rep 37(3) : 24~25

[journal] Lantos J.D. / 1999 / The “inclusion benefit” in clinical trials / J Pediatr 134(2) : 130~131

[journal] Dresser R. / 1992 / Wanted: Single, white male for medical research / Hastings Cent Rep 22(1) : 24~25

[other] National Institutes of Health, Department of Health and Human Services / 1994 / NIH Guidelines on the Inclusion of Woman and Minorities as Subjects in Clinical Research; Notice / Federal Register, 59(59) : 14508~14513

[journal] Johns M.M. / 2003 / Restoring Balance to Industry-Academia Relationships in an Era of Institutional Financial Conflicts of Interest Promoting Research While Maintaining Trust / JAMA 289 : 741~746

[journal] Bekelman J.E. / 2003 / Scope and impact of financial conflicts of interest in biomedical research: A systematic review / JAMA 289 : 454~465

[journal] Editorial / 2005 / This Clinical Trial Fully Registered? — A Statement from the International Committee of Medical Journal / N Engl J Med 352 : 2436~2438

[journal] Emanuel E.J. / 2000 / What makes clinical research ethical? / JAMA 283 : 2701~2711

[journal] Miller, F.A. / 2008 / Duty to disclose what? Querying the putative obligation to return research results to participants / J Med Ethics 34 : 210~213

[web] / 2009 / Code of Federal Regulation Title 45, Public Welfare, Department of Health and Human Services, Part 45, Protection of Human Subjects (45 CFR 46, Effective July 14, 2009) / https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html

[book] Porter J.P. / 2008 / The Oxford Textbook of Clinical Research Ethics / Oxford University Press : 156~158

[book] Yessian M.R. / 2006 / Institutional Review Board: Management and Function / Jones & Bartlett Learning : 10~

[web] Department of Health and Human Services / 2011 / Human subjects research protections: enhancing protections for research subjects and reducing burden, delay, and ambiguity for investigators. Federal Register, 2011;76(143): 44512-44531 / https://www.gpo.gov/fdsys/pkg/FR-2011-07-26/pdf/2011-18792.pdf

[web] / 2011 / ANPRM Frequently Asked Questions (FAQs) July 2011 / https://www.hhs.gov/ohrp/regulations-and-policy/regulations/anprm-faq/index.html

[web] Department of Health and Human Services / 2015 / Federal Policy for the Protection of Human Subjects. Federal Register 2015;80(173):53933-54061 / https://www.gpo.gov/fdsys/pkg/FR-2015-09-08/pdf/2015-21756.pdf

[web] / NPRM 2015 – Summary / https://www.hhs.gov/ohrp/regulations-and-policy/regulations/nprm-2015-summary/index.html

[web] / 2016 / Analysis of Public Comments on the Common Rule NPRM / http://www.cogr.edu/sites/default/files/Analysis%20of%20Common%20Rule%20Comments.pdf

[book] Skloot R. / 2010 / The immortal life of Henrietta Lacks / Crown Publishers

[journal] Hodge J.G. / 2017 / Revamping the US Federal Common Rule: Modernizing Human Participant Research Regulations / JAMA 317(15) : 1521~1522

[journal] Gunsalus C.K. / 2006 / Mission creep in the IRB world / Science 312(5779) : 1441~

KJCKorea
Journal Central

Journal of the Korea Bioethics Association 2023 KCI Impact Factor : 0.55